Podcasts about drug safety

The Radically Genuine podcast welcomes back renowned Maternal-Fetal Medicine (MFM) physician Dr. Adam Urato as he pulls back the curtain on what pregnant women aren't being told about medication risks. Why are doctors spending less than ten minutes on "informed consent" when your child's future is at stake? What caused one medical intervention to be injected into 350,000 pregnant women despite not actually working? Dr. Urato reveals why corporate medicine makes it nearly impossible for physicians to tell patients the truth and explains his bold mission to change FDA labeling. This conversation will force you to question everything you thought you knew about "safe" medications during pregnancy.Chapters00:00 The Vulnerability of Unborn Children02:30 Introduction of Dr. Adam Urato04:08 The Case of McKenna: A Systemic Failure11:17 The Need for Rigorous Safety Evaluations16:33 Chronic Disease Epidemic and Chemical Exposures23:16 Mental Health and Pregnancy: A Complex Debate39:14 Fear Provocation and Informed Consent43:20 Informed Consent and Patient Empowerment46:36 The Challenges of Time in Medical Practice53:09 Risks and Benefits of Psychiatric Medications01:01:05 The Role of Physicians in Patient Advocacy01:06:04 Citizen's Petition and FDA Labeling Changes01:18:00 The Importance of Open Dialogue in Medicine RADICALLY GENUINE PODCASTDr. Roger McFillin / Radically Genuine WebsiteYouTube @RadicallyGenuineDr. Roger McFillin (@DrMcFillin) / XSubstack | Radically Genuine | Dr. Roger McFillinInstagram @radicallygenuineContact Radically GenuineConscious Clinician CollectivePLEASE SUPPORT OUR PARTNERS15% Off Pure Spectrum CBD (Code: RadicallyGenuine)10% off Lovetuner click here—-----------FREE DOWNLOAD! DISTRESS TOLERANCE SKILLS

Medication safety remains a cornerstone of anesthesia practice with complex environments and high-stakes decisions requiring vigilant attention to prevent errors. This collaboration between APSF and OpenAnesthesia spotlights critical aspects of perioperative drug safety with practical insights from Dr. Juan Li, a cardiothoracic anesthesia fellow at Beth Israel Deaconess Medical Center.• Perioperative anaphylaxis requires immediate recognition of cardiovascular, respiratory, and cutaneous manifestations• Neuromuscular blocking agents and antibiotics represent common triggers for anaphylactic reactions• Preoperative assessment must include thorough allergy history, medication reconciliation, and identification of drug-drug interactions• Standardized drug concentrations, preparation methods, and equipment minimize medication errors• Technology integration through barcode readers and computerized decision support enhances safety• Pharmacy support with pre-mixed solutions and pre-filled syringes reduces preparation errors• Post-operative monitoring remains critical for catching delayed medication reactions• Safety culture should emphasize root cause analysis rather than punishment for medication errors• Implementation of standard protocols is essential for managing new medications with limited safety dataVisit APSF.org and Openanesthesia.org for detailed information and resources on medication safety in anesthesia practice.

A Texas child's measles-related death, the first in the U.S. since 2015, highlights rising cases amid declining vaccination rates. AstraZeneca's Serena 6 trial found camizestrant, delayed disease progression in HR-positive HER2-negative breast cancer. A BMJ study found no link between GLP-1 receptor agonists and increased suicidality in diabetes patients. The CDC reports an 80% decline in high-risk cervical precancers, confirming HPV vaccination success.

Jo Cheah talks to Debra Kennedy, director of MotherSafe, about her paper on drug safety in pregnancy. Debra discusses the key considerations when stopping or starting a medicine during pregnancy, and the ways in which medicines can affect developing fetuses. Debra also explains the Australian categorisation system for prescribing medicines in pregnancy. Read the full article by Debra and her co-author, Ronald Batagol, in Australian Prescriber.

Today's guest is Nicole Baker, CEO at biologit. Founded around 2020, biologit - who was a finalist in the Best Application of AI in Healthcare at the 2024 AI Awards - has pioneered an innovative approach to pharmacovigilance, the practice of monitoring the effects of medical drugs after they have been licensed for use.Topics include:0:00 Applying AI and NLP to analyze pharmaceutical literature efficiently3:06 Helping pharma companies and service providers save time4:10 Building AI with open-access literature to analyze unstructured data6:18 How Gen AI isn't fully validated for pharmacovigilance compliance9:14 Pharma adoption of AI is slow due to learning and change management11:19 How AI streamlines event detection and global biomedical data monitoring14:19 Signing 12 new contracts, expanding to top pharma

PJ talks about the upskirt photo investigation centred on MacCurtain St, chats to Grace an amazing lady who is thanking the Mercy after her son, brother and husband had cancer, discusses with George Patterson how drugs policy should help both drug users and those who live in the city. And more... Hosted on Acast. See acast.com/privacy for more information.

Plus AI Artist Makes Millions Like this? Get AIDAILY, delivered to your inbox, every weekday. Subscribe to our newsletter at https://aidaily.us Backflip Unveils AI Model Transforming Text into Physical Reality Backflip, with $30M in funding from NEA and Andreessen Horowitz, introduces an AI model that converts text descriptions into 3D-printable objects. This innovation could revolutionize design processes, enabling rapid prototyping and manufacturing from mere ideas. Botto: The AI Machine Artist Raking in Millions Botto, a decentralized AI artist, has made over $5 million since 2021 by auctioning its digital artworks. With community input guiding its creations, Botto challenges traditional notions of art, creativity, and ownership in the digital age. Chloe Amour Uses AI to Manage High Demand in Adult Industry Chloe Amour leverages AI to handle her booming career in adult entertainment, using it for everything from content creation to fan interaction. This use of technology showcases how AI can transform personal branding and content scalability in digital spaces. Korea Approves First AI Software for Depression Screening South Korea's Ministry of Food and Drug Safety has approved ACRYL-D01, the first AI-powered software for diagnosing depression. It aims to assist clinicians by quantifying depression probability through digital analysis of patient interviews, marking a significant step in mental health tech. Creating a Real-Life 'Her': Designing AI for Seamless Conversational Experience Natura Umana is leveraging AI to create conversational experiences that echo the naturalness seen in "Her". The challenge lies in achieving genuine, context-aware dialogue, pushing the boundaries of what AI can do in everyday interactions. Studies Warn: AI Use May Diminish Human Cognitive Skills Recent research indicates that over-reliance on AI for tasks like writing and decision-making might lead to a decline in cognitive abilities such as critical thinking and memory. This raises concerns about the long-term impact of AI on human intelligence. AI Agents: The New Personal Assistants or Manipulation Engines? AI agents promise personalized assistance but carry the risk of becoming manipulation tools. By knowing our schedules and preferences, they could subtly influence our choices, raising concerns about privacy, autonomy, and the ethical use of AI in daily life.

MEDBOARD: https://www.medboard.com/ EUROPE TEAM-NB high level position - Making Medical Devices Safer and Faster: https://www.team-nb.org/wp-content/uploads/2024/12/Team-NB-HighLevel-Strategy- PositionPaper-20241130.pdf -   MDCG 2024-15 - Reporting Medical Device Trials Made Easy!: https://health.ec.europa.eu/document/download/0e076d19-62dc-4ff9-83f2-be6072a45993_en? filename=mdcg_2024-15_en.pdf -   EMA activities on Combination products - Reminder on Drug-Device assessment.: https://www.ema.europa.eu/en/documents/presentation/presentation-sme-info-day- session-4-ema-activities-medical-devices_en.pdf -   MDCG 2024-16 Interruption or Discontinuation - For certain devices: https://health.ec.europa.eu/document/download/b431b10f-8512-4f47-9191-e1b84b2f9a27_en? filename=mdr_qna-article10a_mdr-ivdr_en.pdf and annex https://health.ec.europa.eu/document/download/b4a7dea7-ae73-4e13-a8a8-11dcd2678d38_en?filename=md_mdc-2024-16 _annex_en.pdf -   Joint Paper from 9 Member states - Council of the European Union: https://data.consilium.europa.eu/doc/document/ST-15380-2024-INIT/en/pdf Reduction of Administrative Burdens Centralization of System Management to the EMA Predictable Certification Procedures Enhanced Coordination and Support Impact Assessment and Resource Allocation   -   MDCG 2024-14 Master UDI-DI - Contact lenses: https://health.ec.europa.eu/document/download/c8c6cca5-460e-410e-a325-be08bfc7dea6_en?filename=mdcg_2024-14 _en.pdf Master UDI-DI Assignment Labelling Requirements Vigilance Reporting EUDAMED Registration Implementation Timeline   -   Artificial Intelligence in Medical Devices . Joint publication Team NB and IG-NB: https://www.team-nb.org/wp-content/uploads/2024/11/Team-NB-PositionPaper-AI-in-MDQuestionnaire-V1-20241125.pdf -   Gradual Roll-out of EUDAMED - Be ready to start: https://health.ec.europa.eu/document/download/0e7327c7-0e06-4fbd-90d3-8ab7bb30fe9f_en?filename=md_mdcg_2024-11_eudamed-qa.pdf -   Spain application for in-house devices - For hospitals: https://www.aemps.gob.es/informa/la-aemps-pone-en-marcha-una-nueva-aplicacion-para-la-comunicacion-de-fabricacion-de-productos-sanitarios-in-house-por-hospitales/ SMARTEYE - Eqms Smarteye: https://eqms-smarteye.com/ EVENTS - Arab Health - January 27 to 30th, 2025: https://medtechconf.com/event/total-radiology-conference/ TRAINING -  Mini-Course MDR: https://easymedicaldevice.com/resource/resource-medical-device-regulation/mini-course-mdr/ ROW -   US - Some healthcare software are not devices - WARNING: https://www.fda.gov/media/184083/download?attachment Administrative support in healthcare settings. Promoting healthy lifestyles without direct links to disease management. Serving as electronic patient records without interpreting or analyzing data. Transferring, storing, converting, or displaying medical data without interpretation. Providing limited clinical decision support to healthcare providers without interpreting clinical tests or device data.   -   US - PCCP Final guidance - Submit a PCCP with your submission: https://www.fda.gov/media/166704/download • Webinar January 14, 2025 - https://www.fda.gov/medical-devices/cdrhnew-news-andupdates/webinar-final-guidance-marketing-submission-recommendations-predetermined-change-control-plan?utm_source=FDALinkedin - South Korea Guidance - Enhancing Medical Device Safety!: https://www.mfds.go.kr/law/board/boardDetail.do?menuKey=29&brdId=data0011&seq=15564 we're talking about new guidance from South Korea's Ministry of Food and Drug Safety, or MFDS. They just released a document to help improve the safety and quality of medical devices." "This guidance focuses on stricter standards for manufacturing and testing medical devices to ensure they are safe and effective for patients." "The MFDS is also emphasizing the importance of proper documentation and reporting, so that any issues can be quickly identified and addressed." The MFDS aims to make medical devices safer through several key measures: Stricter Standards: They are implementing more rigorous manufacturing and testing standards to ensure devices meet high safety and quality benc Enhanced Oversight: Increased oversight and regular inspections of manufacturing processes ensure compliance with safety regulations. Training and Education: Providing training and resources to manufacturers to help them understand and meet the new standards. These steps are designed to ensure that medical devices are safe, effective, and reliable for patients. "In short, this new guidance aims to make medical devices safer and more reliable for everyone." -  Australia - Guidelines for Medical Devices - Bookmark the link: https://www.tga.gov.au/resources/resource/reference-material/australian-regulatory-guidelines-medical-devices- argmd -  Australia - Submit Custom-made device - Guidance step-by-step: https://www.tga.gov.au/resources/resource/user-guide/how-submit-custom-made-medical-device-notification -  Malaysia - Advertisement application - Approve your Advertising: https://www.mda.gov.my/index.php/industry/medical-device-advertisements/medical-device-advertisement PODCAST -  How MDR and IVDR code can save you money? Stefan Bolleininger: https://podcast.easymedicaldevice.com/309-2/ -  Is FMEA bad for your Risk Management? Rod Beuzeval: https://podcast.easymedicaldevice.com/310-2/ -  How to build the perfect Quality Management System? https://podcast.easymedicaldevice.com/311-2/ -  IEC 60601-1-8 How to test your Medical Device Alarms? Beat Keller https://podcast.easymedicaldevice.com/312-2/ -  PCCP - The magic tool for planned changes in the US? Maria Diez: https://podcast.easymedicaldevice.com/313-2/ Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice

Good morning from Pharma and Biotech Daily: the podcast that gives you only what's important to hear in Pharma and Biotech world. ## Breakthrough in Cancer Treatment ##Researchers have discovered a new combination therapy that has shown promising results in treating certain types of cancer. The therapy combines immunotherapy with targeted therapy, enhancing the body's immune response to cancer cells while also attacking the tumors directly. This breakthrough could potentially revolutionize cancer treatment and improve outcomes for patients.## FDA Approves New Drug for Rare Disease ##The FDA has approved a new drug for the treatment of a rare genetic disease that affects a small subset of the population. The drug has shown significant efficacy in clinical trials, providing hope for patients who previously had limited treatment options. This approval marks a milestone in the advancement of precision medicine and personalized healthcare.## Biotech Company Announces Partnership ##A leading biotech company has announced a new partnership with a pharmaceutical giant to collaborate on the development of a groundbreaking gene therapy. The partnership will combine the expertise and resources of both companies to accelerate the development and commercialization of this potentially life-changing therapy. This collaboration highlights the importance of industry partnerships in driving innovation and advancing medical research.## Clinical Trial Shows Promising Results ##A recent clinical trial has demonstrated promising results for a new drug candidate aimed at treating a common chronic condition. The drug showed significant efficacy in reducing symptoms and improving quality of life for patients, with minimal side effects reported. These findings suggest that the drug could become a valuable treatment option for millions of individuals suffering from this condition.## Regulatory Update: FDA Issues Warning ##The FDA has issued a warning regarding the potential risks associated with a popular over-the-counter medication. The warning highlights concerns about potential side effects and interactions with other medications, urging healthcare providers to exercise caution when prescribing this drug. This regulatory update serves as a reminder of the importance of monitoring drug safety and efficacy to protect patient health.## Industry News: Merger Announcement ##Two major pharmaceutical companies have announced plans to merge, creating one of the largest pharmaceutical companies in the world. The merger is expected to result in significant cost savings and synergies, as well as enhance research and development capabilities. This industry news underscores the ongoing trend of consolidation within the pharmaceutical industry and the impact it can have on innovation and competition.## Research Breakthrough: New Drug Target Identified ##Researchers have identified a promising new drug target for the treatment of a complex neurological disorder. By targeting this specific pathway, researchers believe they can develop more effective treatments with fewer side effects. This discovery represents a significant step forward in understanding the underlying mechanisms of this disorder and could lead to improved therapeutic options for patients in the future.## Market Update: Biotech Stocks Surge ##Biotech stocks have surged following positive news from several companies regarding clinical trial results and regulatory approvals. Investors are optimistic about the future potential of these companies' pipelines and are driving up stock prices as a result. This market update reflects the strong investor interest in biotech companies and their potential for growth and innovation in the healthcare sector.In conclusion, these recent developments in the Pharma and Biotech world demonstrate the ongoing progress and innovation happening within the industry. From breakthrough treatments to regulatory updates, industry partnerships to market

While structured data elements such as patient identifier, medicine name and reaction, are fundamental for adverse event reporting, they may not capture all relevant details. This is where the narrative fields come in, allowing reporters to disclose important contextual information, such as the patient's full clinical course. But how do PV assessors interact with these narratives in spontaneous reports? What needs and challenges do they experience? These and other questions were addressed in an exploratory interview study by UMC researchers Joana Félix and Alem Zekarias.  Tune in to find out:What challenges are PV assessors faced with, when working with narratives? How could automation of certain tasks help streamline narrative analyses in the future?How can reporters craft narratives that effectively document adverse events? Want to know more?Pharmacovigilance assessors' experiences interacting with narrative fields in spontaneous reports: an exploratory interview study – poster presented at the 23rd ISoP Annual Meeting “Global Perspectives on Pharmacovigilance in the Digital Age and Advanced Therapeutics”, 1–5 October 2024 Montreal, Canada.Current Challenges in Pharmacovigilance: Pragmatic Approaches, by The Council for International Organisations of Medical Sciences (CIOMS). See page 133 on the role of narratives in good case management practices. Join the conversation on social mediaFollow us on X, LinkedIn, or Facebook and share your thoughts about the show with the hashtag #DrugSafetyMatters.Got a story to share?We're always looking for new content and interesting people to interview. If you have a great idea for a show, get in touch!About UMCRead more about Uppsala Monitoring Centre and how we work to advance medicines safety.

In this episode, Dr. Jessica Steier and Dr. Sarah Scheinman welcome Dr. Namandjé Bumpus, Principal Deputy Commissioner of the FDA, who shares insights into the agency's operations and her path from academia to FDA leadership. The scientists explore the complexities of drug approval processes, the FDA's organizational structure, and its commitment to safety and transparency. Dr. Bumpus discusses the agency's efforts to advance health equity and adapt to emerging technologies, while addressing the critical challenge of maintaining public trust. This conversation offers listeners a unique glimpse into the inner workings of the FDA and its role in protecting public health. All our sources from this episode are available at: https://www.unbiasedscipod.com/episodes/ (00:00) Introduction  (03:31) Dr. Bumpus' Academic and Professional Journey (06:19) Transition from Academia to FDA Leadership (09:10) The Role of Pharmacology in Public Health (12:26) Overview of FDA Offices and Centers (15:10) Understanding the Drug Approval Process (18:12) Post-Market Surveillance and Drug Safety (21:20) Building Trust in Government Agencies (24:27) Examples of FDA's Impact on Public Health (27:16) Ensuring Transparency in FDA Processes (30:27) The Human Foods Program and Its Importance (33:08) Adapting to Rapidly Evolving Technologies (36:16) Challenges Facing the FDA and Public Health (38:42) Final Thoughts Interested in advertising with us? Please reach out to advertising@airwavemedia.com, with “Unbiased Science” in the subject line. PLEASE NOTE: The discussion and information provided in this podcast are for general educational, scientific, and informational purposes only and are not intended as, and should not be treated as, medical or other professional advice for any particular individual or individuals. Every person and medical issue is different, and diagnosis and treatment requires consideration of specific facts often unique to the individual. As such, the information contained in this podcast should not be used as a substitute for consultation with and/or treatment by a doctor or other medical professional. If you are experiencing any medical issue or have any medical concern, you should consult with a doctor or other medical professional. Further, due to the inherent limitations of a podcast such as this as well as ongoing scientific developments, we do not guarantee the completeness or accuracy of the information or analysis provided in this podcast, although, of course we always endeavor to provide comprehensive information and analysis. In no event may Unbiased Science or any of the participants in this podcast be held liable to the listener or anyone else for any decision allegedly made or action allegedly taken or not taken allegedly in reliance on the discussion or information in this podcast or for any damages allegedly resulting from such reliance. The information provided herein do not represent the views of our employers. Learn more about your ad choices. Visit megaphone.fm/adchoices

The horseshoe crab has endured for over 450 million years. It has survived several mass extinctions including the one that killed off the dinosaurs. One reason for their incredible resiliency is their ability to fend off bacterial infection. Their blood contains cells that clot around invading bacteria, thereby protecting them from the attacking toxins.In this episode we talk with three experts about how this animal's unique blue blood has become essential to modern medicine. We also talk about why horseshoe crab populations are dwindling, and what biotech is doing to address the shortfall.Follow us on LinkedIn, X, Facebook and Instagram. Visit us at https://www.bio.org/

In this episode of Vibe Science, Ryan Alford andChris Hansen sit down with Kat Murti, Executive Director of Students for Sensible Drug Policy (SSP), and Gina Giorgio to dive into the topic of drug policy reform. Kat shares SSP's mission to end the war on drugs and advance policies that prioritize human rights and harm reduction. The discussion explores the historical background of drug laws, racial disparities in enforcement, and the critical role of education and community support in tackling addiction. The guests advocate for a compassionate, evidence-based approach to drug use, questioning the effectiveness of punitive policies and calling for change.TAKEAWAYSDrug policy reform and its societal implicationsThe mission and role of Students for Sensible Drug Policy (SSP)Historical context of drug laws and their impact on societyRacial disparities in drug enforcement and sentencingThe negative consequences of punitive drug policies on individuals and communitiesThe relationship between addiction and environmental factorsThe concept of "set and setting" in drug use experiencesThe critique of the criminal model of drug policyThe importance of education and harm reduction in addressing drug useThe need for a compassionate and informed societal approach to drug use and addiction Follow us on Instagram: @Vibe.Science Subscribe to our YouTube Page: www.youtube.com/@Vibe.Science

Medication-related-harm (MRH) is especially prevalent in older adults due to changing physiology as the body ages, increased frailty, and the incidence of polypharmacy in this patient group. Giovanni Furlan of Pfizer discusses what makes this patient group so vulnerable to adverse drug reactions, how poor representation and using age alone to define older adults exacerbates this problem, and suggests ways forward in monitoring drug safety in older patients. Tune in to find out:What makes older adults especially at risk of experiencing adverse drug reactions and medication errorsWhy frailty is far more useful than age in predicting adverse drug reaction riskHow pharmacovigilance in older patients may be improved through pharmaceutical practice and better representation in clinical trials.Want to know more?This interview all started with Giovanni's Uppsala Reports article on how age is insufficient a measure of adverse event risk. Read it here.For a summary of the key points discussed in this interview, read Giovanni's paper on the status of drug safety in geriatric patients.If our discussion of frailty piqued your interest, read this paper on the biology of frailty and how this impacts clinical pharmacology, this multi-centre cohort study that shows frailty is significantly correlated with MRH, and this commentary advocating for consideration of MRH as a geriatric syndrome, which needs to be managed as such. As Giovanni mentioned in the interview, Harlan Krumholz was the first to describe post-hospital syndrome. Learn more about this syndrome by reading his paper.For more on prescribing cascades, their prevention, detection, and reversal, read this paper by Brath and colleagues.Join the conversation on social mediaFollow us on X, LinkedIn, or Facebook and share your thoughts about the show with the hashtag #DrugSafetyMatters.Got a story to share?We're always looking for new content and interesting people to interview. If you have a great idea for a show, get in touch!About UMCRead more about Uppsala Monitoring Centre and how we work to advance medicines safety.

Welcome to the Evidence-Based Hair Podcast, hosted by dermatologist and hair loss specialist Dr. Jeff Donovan. As the director of the Donovan Hair Academy, Dr. Donovan is dedicated to educating both the public and practitioners about hair loss through comprehensive training programs like the Evidence-Based Hair Fellowship. In this episode, Dr. Donovan delves into the critical topic of JAK inhibitors and their safety during pregnancy. He explores a pivotal study published in Drug Safety that examines pregnancy outcomes in patients treated with Upadacitinib, a JAK inhibitor used for various inflammatory disorders, including alopecia areata. The episode provides an in-depth analysis of data from clinical trials and post-marketing reports, highlighting the impact of JAK inhibitors on pregnancy outcomes, such as congenital anomalies and live births. Dr. Donovan discusses the importance of understanding the safety of these medications in pregnancy and emphasizes the need for more research in this area. Listeners will gain valuable insights into the complexities of managing hair loss treatments during pregnancy and the challenges faced by patients and clinicians alike. Dr. Donovan also shares promising findings and case studies involving other JAK inhibitors, offering a comprehensive overview of the current landscape and future directions in this field. Join us for this informative episode as Dr. Donovan addresses a pressing concern in the world of hair loss and pregnancy, providing expert analysis and guidance for both practitioners and patients.     REFERENCES Uma Mahadevan et al. Pregnancy Outcomes in Patients Treated with Upadacitinib: Analysis of Data from Clinical Trials and Postmarketing Reports. Drug Saf . 2024 Oct;47(10):1039-1049. doi: 10.1007/s40264-024-01454-0. Epub 2024 Jul 15.   Megan E B Clowse et al. Pregnancy Outcomes in the Tofacitinib Safety Databases for Rheumatoid Arthritis and Psoriasis. Drug Saf . 2016 Aug;39(8):755-62. doi: 10.1007/s40264-016-0431-z.   Mahadevan U et al. Outcomes of Pregnancies With Maternal/Paternal Exposure in the Tofacitinib Safety Databases for Ulcerative Colitis. Inflamm Bowel Dis. 2018 Nov 29;24(12):2494-2500. doi: 10.1093/ibd/izy160.

In this episode of The Amberly Lago Show: Stories of True Grit and Grace, host Amberly Lago sits down with Kim Witczak to explore the profound journey of turning grief into advocacy and healing. Kim shares her touching story following the tragic loss of her husband, Woody, and how this life-altering event propelled her into challenging big pharmaceutical companies for better drug safety. They discuss the importance of faith, community, and finding hope in moments of despair. Kim also reflects on the symbolism of butterflies as signs from her late husband and the transformative power of personal growth through adversity. Join Amberly and Kim as they delve into topics of resilience, advocacy, and the emotional pathways of healing in this moving and empowering conversation. If you are ready to leave your mark by discovering your message and sharing it with the world, you've come to the right place!! Let's work together to build your influence, your impact, and your income! Join the tribe you have been waiting for to activate your highest potential and live the life you deserve! Join the “Unstoppable Life Mastermind!” and let us know you are ready for greatness! Read the “True Grit and Grace” book here and learn how you can turn tragedy into triumph!  Thank you for joining us on The Amberly Lago Show: Stories of True Grit and Grace! If you find value in today's episode, don't forget to share the show with your friends and tap that subscribe button so you don't miss an episode! You can also head over to amberlylago.com to join my newsletter and access free downloadable resources that can help you elevate your life, business, and relationships! Want to see the behind-the-scenes and keep the conversation going?  Head over to Instagram @amberlylagomotivation! Audible @True-Grit-and-Grace-Audiobook  Website @amberlylago.com Instagram @amberlylagomotivation Facebook @AmberlyLagoSpeaker

If anything positive came from the pandemic, it's that people became more aware of Big Pharma and realized that a pill isn't the solution to every problem. There's now a healthy skepticism, especially when the government pushes a pill or shot. It's important for all of us to ask questions. My next guest, Kim Witczak, tragically lost her husband 21 years ago and is here to share her story. She's a global drug safety advocate.

Are we given true informed consent with every drug we are offered? Are the known side effects always disclosed? It would be nice to think so, but the truth is, Big Pharma and the FDA actually go to great lengths to keep us in the dark about certain truths that can harm us because they harm their bottom line. On this episode of Vitality Radio, Jared invites Kim Witczak to join him in an important discussion about this issue. After the sudden death of her husband due to an undisclosed side effect of an antidepressant, Kim Witczak became an advocate for pharmaceutical drug safety and reform. Jared and Kim discuss the impact antidepressants have on suicide and violence. As Kim says, healthcare is a business, and we are customers. She is not anti-drug but pro-information and she continues to stand up to the Big Pharma and FDA machines to demand honesty, transparency, reform and accountability - for all of us.Additional Information:Websites: www.kimwitczak.comwww.woodymatters.comTwitter: @woodymattersInstagram: @kim_witczakSubstack: (UN)acceptable Collateral Damage#381: VR Vintage: The Truth and Theory Behind Antidepressants#264: Emotional Vitality: Jen's Story Part 1 - From Addiction and Mental Illness to VitalityVisit the podcast website here: VitalityRadio.comYou can follow @vitalityradio and @vitalitynutritionbountiful on Instagram, or Vitality Radio and Vitality Nutrition on Facebook. Join us also in the Vitality Radio Podcast Listener Community on Facebook. Shop the products that Jared mentions at vitalitynutrition.com. Let us know your thoughts about this episode using the hashtag #vitalityradio and please rate and review us on Apple Podcasts. Thank you!Please also join us on the Dearly Discarded Podcast with Jared St. Clair.Just a reminder that this podcast is for educational purposes only. The FDA has not evaluated the podcast. The information is not intended to diagnose, treat, cure, or prevent any disease. The advice given is not intended to replace the advice of your medical professional.

Andrew Dudum, CEO of Hims & Hers, joined Leading Indicator to break down the company's latest earnings report, the rising demand for its compounded obesity drug, the recent $31 million acquisition of a compounding pharmacy, and the rapidly growing business for women's healthcare. Hosted by Hope King, Senior Business Reporter at Axios. (Recorded August 6, 2024) The content of the video is for general and informational purposes only. All views presented in this show reflect the opinions of the guest and the host. You should not take a mention of any asset, be it cryptocurrency or a publicly traded security as a recommendation to buy, sell or hold that cryptocurrency or security. Guests and hosts are not affiliated with or endorsed by Public Holdings or its subsidiaries. You should make your own financial and investment decisions or consult respective professionals. Full disclosures are in the channel description. Learn more at Public.com/disclosures. Past performance is not a guarantee of future results. There is a possibility of loss with any investment. Historical or hypothetical performance results, if mentioned, are presented for illustrative purposes only. Do not infer or assume that any securities, sectors or markets described in the videos were or will be profitable. Any statements of future expectations and other forward-looking statements are strictly based on the current views, opinion, or assumptions of the person presenting them, and should not be taken as an indicator of performance nor should be relied upon as an investment advice.

Suzanne Robotti is an FDA Consumer Representative, Drug Side Effects Expert, DES Daughter, and founder of MedShadow Foundation, a nonprofit organization which encourages people to think for themselves, not to believe everything you read online, do your own diligent research, and balance the benefits with the risks of medications. She launched MedShadow Foundation in 2013 because she herself was harmed by a medication called DES that was given to her mother when she was pregnant with Su. At the young age of 13, Su learned that she would never be able to have children because of the harmful side effects of DES. Generations later, DES has been found to cause rare cancers, autoimmune diseases, and infertility. In 2017 Su was appointed to the FDA Advisory Committee on Drug Safety and Risk Management as the lone consumer representative on a panel of doctors and pharmacists. She considers it a privilege to have a seat at the table when the FDA is deciding if a drug is safe and effective enough to use.   Su shares her own personal story of dealing with the harmful side effects of DES, as well as the many other side effects that other DES mothers, children, grandchildren, and great-grandchildren continue to deal with, only because “modern medicine” believed that medications were not able to cross from an expectant mother to her unborn child. This led to not only one generation being impacted by the harmful effects of the first synthetically manufactured estrogen which was given to pregnant women between 1940 to 1971 to prevent miscarriage and related complications of pregnancy.   Su explains how her own experience caused her to look deeper into medications which are prescribed, as well as potential side effects. Her research and due diligence went into high gear when her nephew who was living with her and her husband, was diagnosed with ADHD at the age of 12. He was subscribed large doses of approved ADHD medications, the doctors told Su and her family that he would keep trying various medications to “get that kid under control.” When Su asked what the potential side effects were, the doctor assured her that there weren't any. When she asked to see the studies, he laughed and said there weren't any, but again reassured her that they were perfectly safe. Download this informative episode to hear Su's story, and discover how she and her family were able to help their nephew deal with his ADHD without medication, the importance and impact of healthy living, how to become your own health advocate, how to get involved with your own medication regime by collaborating and communicating with both your doctor and pharmacist, why it's important to consider your options, how to balance the benefits with the risks of medications.         https://medshadow.org/ https://www.facebook.com/medshadow.foundation https://www.tiktok.com/@medshadow_foundation?lang=en https://www.instagram.com/medshadowfoundation/?hl=en https://twitter.com/Med_Shadow? https://www.linkedin.com/in/suzannerobotti/ https://www.youtube.com/user/MedShadowFoundation  

Ensuring trust in AI is vital to fully reap the benefits of the technology in pharmacovigilance. Yet, how do we do so while grappling with its ever-growing complexity?This episode is part of the Uppsala Reports Long Reads series – the most topical stories from UMC's pharmacovigilance news site, brought to you in audio format. Find the original article here.After the read, we speak to one of the authors of the article, Michael Glaser, to learn more about how AI and ML has been used in pharmacovigilance so far, and what needs to happen to ensure its continued use in the field.Tune in to find out:●      How AI and ML are being used today in pharmacovigilance processes●     Why a mindset change is necessary to make full use of AI/ML in pharmacovigilance●      How we may best move forward to implement AI/ML into healthcare. Want to know more? To know more about how AI and ML are being used in pharmacovigilance currently, read this scoping review.To know more about future trends of the use of AI in Biopharma, read this Accenture survey.Despite there being major interest in ML and AI to do more than task automation, there are a number of barriers to its implementation in healthcare. Check out this future-focused paper on the use of AI/ML in pharmacovigilance that details how to utilise it to its fullest potential.A mindset shift is necessary in terms of how we think about data, in terms of sharing, how to generate data required to effectively train AI/ML models.A validation framework must be developed for AI-based pharmacovigilance systems. One suggestion is to do so using a risk-based approach.While there is much interest in using recently developed AI technologies such as chatGPT, preliminary studies like this one suggest that the technology has a ways to go to be useful in pharmacovigilance.The World Health Organization have published an extensive guideline on the ethics and governance of AI for health.Join the conversation on social mediaFollow us on X, LinkedIn, or Facebook and share your thoughts about the show with the hashtag #DrugSafetyMatters.Got a story to share?We're always looking for new content and interesting people to interview. If you have a great idea for a show, get in touch!About UMCRead more about Uppsala Monitoring Centre and how we work to advance medicines safety.

In this June series of the podcast, we focus on JAK inhibitors. This episode kicks off with a detailed review of an Italian study published in Expert Opinion in Drug Safety, which examines the incidence and management of infections in patients with alopecia areata treated with JAK inhibitors. Dr. Donovan discusses the findings, emphasizing that about one in three patients on JAK inhibitors may develop infections, highlighting the need for careful monitoring and potential treatment pauses. Additionally, Dr. Donovan reviews a study from New York in Archives of Dermatologic Research, which reveals low vaccination rates among patients with immune-mediated diseases on biologics and JAK inhibitors. The study underscores the importance of pre-treatment vaccinations to mitigate infection risks. Join us next week as we explore the efficacy and cost benefits of generic tofacitinib in managing alopecia areata, part of our ongoing series on JAK inhibitors. Stay tuned for more insights and expert analysis on the Evidence-Based Hair Podcast.   STUDIES REFERENCE IN THIS WEEK'S EPISODE     Giacomo Caldarola et al. Infectious events in patients with alopecia areata treated with JAK inhibitors: low burden and minimal impact on persistence in treatment. Expert Opin Drug Saf. 2024 May 8:1-5.   Hren MG and Khattri S. Low rates of vaccination among atopic dermatitis, alopecia areata, psoriasis, and psoriatic arthritis patients on biologics. Arch Dermatol Res. 2024 May 25;316(6):285

About this episode: One in five U.S. adults is taking five or more prescription drugs at a time, often for years without reassessment of need, dosage, or possible interactions. Today, a look at polypharmacy and why it's important for physicians to periodically check in with patients about all the prescription—and nonprescription—drugs they're taking. The guests also discuss the importance of considering non-pharmaceutical treatments like physical or talk therapy, and empowering patients and their care partners to ask questions about what they're being prescribed. Guests: Dr. Cynthia Boyd is a geriatrician and faculty at Johns Hopkins Medicine. She is also a senior associate with the Johns Hopkins Center on Aging and Health. Dr. Ariel Green is a geriatrician and faculty at Johns Hopkins Medicine. She is also a core faculty member of the Johns Hopkins Bloomberg School of Public Health Center for Drug Safety and Effectiveness. Host: Stephanie Desmon, MA, is a former journalist, author, and the director of public relations and communications for the Johns Hopkins Center for Communication Programs, the largest center at the Johns Hopkins Bloomberg School of Public Health. Show links and related content: Taking Multiple Medications? You May Need to Scale Back.—The New York Times Taking more than 5 pills in a day? ‘Deprescribing' can prevent harm—especially for older people—The Conversation Contact us: Have a question about something you heard? Want to suggest a topic or guest? Contact us via email or visit our website. Follow us: @‌PublicHealthPod on X @‌JohnsHopkinsSPH on Instagram @‌JohnsHopkinsSPH on Facebook @‌PublicHealthOnCall on YouTube Here's our RSS feed

As women go through menopause and beyond, hormonal changes affect how they react to medications! Join Jeanne as she speaks with Suzanne Robotti about safe treatments for women during and after menopause. Women should work closely with their doctors to manage their medication and deal with any risks or side effects! Here are the things to expect in the episode:The effects of drugs and their side effects as people age.How do medications impact women as they navigate through menopause and beyond?Consulting pharmacists and drug reviews.Why is it important for women to exercise caution when considering herbal supplements?And much more! About Suzanne:Suzanne Robotti started MedShadow Foundation in 2013 because she was harmed by a medicine called DES (diethylstilbestrol) that was given to her mother while pregnant and, as a result, was unable to have children. Generations later, this hormone disruptor has been found to cause rare cancers, autoimmune diseases and infertility.In 2017, Robotti was appointed to the FDA Advisory Committee on Drug Safety and Risk Management, joining a panel of doctors and pharmacists as the sole consumer representative. Together, the Committee reviews research and decides if a drug is safe enough for use. Connect with Suzanne Robotti!Website: https://medshadow.org/Healthline: https://www.healthline.com/health/anticholinergicsBeers List (Printable Version): https://www.pharmacyquality.com/wp-content/uploads/2019/05/Beers-List-350301.pdf Connect with me, Jeanne Andrus!Website: https://menopausematterspodcast.com/Email: jeanne@menopause.guruFacebook: https://www.facebook.com/Menopause.Matters.The.PodcastTalk with Me: https://mg.menopause.guru/book-invitationSign up for the workshop at https://menopause.guru/holiday Find out how you can take control of your menopause journey!Schedule your FREE consultation now at menopause. guru/consult. Think Again! Clearing Away the Brain Fog of Menopause can be purchased at https://www.amazon.com/Think-Again-Clearing-Brain-Menopause-ebook/dp/B076H4PJ7G/ Music from #Uppbeat (Free For Creators!): Aurora by Roo Walker https://uppbeat.io/track/roo-walker/aurora?rt=uc-referralLicense code: 6BNDRM6ZKOHCYGCB

Matt Grissinger, RPh, FISMP, FASCP is the Director of Education at the Institute for Safe Medication Practices (also known as ISMP).  During our conversation, we talk about ISMP's Targeted Medication Safety Best Practices for Community Pharmacy first.  Then, we talk about how to report an error, CPE available from past ISMP webinars, adding education on operations to the pharmacy school curriculum, and more.  This is a great episode for any pharmacist, pharmacy student, pharmacy technician, or pharmacy owner.  Medication Safety is important.     Thank you for listening to episode 280 of The Pharmacist's Voice ® Podcast!   To read the FULL show notes, visit https://www.thepharmacistsvoice.com/podcast.  Select episode 280.   Subscribe to or follow The Pharmacist's Voice ® Podcast to get each new episode delivered to your podcast player and YouTube every time a new one comes out!     Apple Podcasts   https://apple.co/42yqXOG  Spotify  https://spoti.fi/3qAk3uY  Amazon/Audible  https://adbl.co/43tM45P YouTube https://bit.ly/43Rnrjt   Bio (May 2024) Matthew Grissinger, RPh, FISMP, FASCP is the Director of Education at the Institute for Safe Medication Practices (ISMP). He first joined ISMP in 2000 as an ISMP Safe Medication Management Fellow. Prior to joining ISMP, he served as a home care and long-term care pharmacy surveyor for the Joint Commission. He was project leader for the Hospital and Healthsystem Association of Pennsylvania (HAP) Hospital Improvement Innovation Network's (HIIN) Adverse Drug Event (ADE) Project, a collaborative project engaging healthcare organizations to reduce and prevent patient harm from the use of anticoagulants, insulins, and opioids. He has published numerous articles in the pharmacy literature, including regular columns in P&T and is a journal reviewer for a number of publications including the Joint Commission Journal on Quality and Patient Safety, Pharmacoepidemiology, Journal of Managed Care and Specialty Pharmacy, BMJ Quality and Drug Safety, and Annals of Internal Medicine. He is a chapter contributor to a textbook published by McGraw-Hill entitled Pharmacy Management: Essentials for All Practice Settings, Essentials of Nurse Informatics, Remington: The Science and Practice of Pharmacy, and Medication Errors. He is recently completed the Just Culture certification course. Mr. Grissinger serves as the Chair for the National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP), and Co-Chair of the National Quality Form (NQF) Common Formats Expert Panel. He is also on the Faculty Advisory Board for the Pharmacy Learning Network (PLN) and the Publications Advisory Board for Davis's Drug Guide for Nurses. He also served on the WHO Focus Group on Measurement Tools for Medication Safety, United States Pharmacopeia's (USP) Safe Medication Use Expert Committee from 2005-2010, the FDA Proprietary Name Review Concept Paper workshop panel in 2008, FDA Naming, Labeling, and Packaging Practices to Minimize Medication Errors workshop panel in 2010 and the Joint Commission Home Care Compounding Pharmacy Technical Advisory Panel in 2013. He is also an adjunct assistant professor for Temple University School of Pharmacy. Mr. Grissinger received a BS in Pharmacy from the Philadelphia College of Pharmacy and Science and is a fellow of the Institute for Safe Medication Practices as well as the American Society of Consultant Pharmacists.   Subscribe to or follow The Pharmacist's Voice ® Podcast to get each new episode delivered to your podcast player and YouTube every time a new one comes out!     Apple Podcasts   https://apple.co/42yqXOG  Spotify  https://spoti.fi/3qAk3uY  Amazon/Audible  https://adbl.co/43tM45P YouTube https://bit.ly/43Rnrjt   Links from this episode Matt Grissinger on LinkedIn https://www.linkedin.com/in/matthew-grissinger-63231ab/  ISMPs new website

Look-alike medicines, unclear communication and distractions during administration – medication errors may occur for many different reasons. They all have in common that they are unintended mistakes in the drug treatment process that may or may not lead to patient harm. In this episode Ghita Benabdallah and Loubna Alj from the national pharmacovigilance centre of Morocco, and Alem Zekarias from Uppsala Monitoring Centre discuss how we can prevent medication errors from occurring – and, when they do occur, make sure that they are reported as such. Tune in to find out:What are the most common causes for medication errors?How should strategies for preventing medication errors be devised? How does the assessment of suspected medication error reports differ from “regular” ADR signal assessment?What can be done to encourage healthcare professionals to report medication errors?Want to know more?In March 2024, WHO published this systematic review of the global burden of preventable medication-related harm in healthcare.According to this 2021 article in BMJ, an estimated 237 million medication errors occur in England every year. Avoidable adverse drug events were calculated to cost the National Health Service an annual sum of GBP 98 462 582 per year, consuming 181 626 bed-days, and causing/contributing to 1708 deaths. This 2012 meta-analysis confirmed what had been suggested in several observational studies: that preventable adverse drug reactions are a significant healthcare burden.The European Medicines Agency (EMA) has a dedicated webpage with recommendations, guidelines, legal requirements and a good practice guide on medication errors. Join the conversation on social mediaFollow us on X, LinkedIn, or Facebook and share your thoughts about the show with the hashtag #DrugSafetyMatters.Got a story to share?We're always looking for new content and interesting people to interview. If you have a great idea for a show, get in touch!About UMCRead more about Uppsala Monitoring Centre and how we work to advance medicines safety.

We are delighted to partner with Soundable Health for our milestone 100th episode of the Prostate Health Podcast! Did you know that you can now monitor the health of your prostate and bladder in the comfort of your home?  We have a special guest, Dr. Catherine Song, joining us today to introduce and guide you through the features of a cutting-edge new mobile app called proudP, which has demonstrated its value for men as a personal prostate health monitor, and for urologists, providing valuable uroflow data without the need for expensive and cumbersome equipment. Dr. Song is the Founder and CEO of Soundable Health, a digital health startup developing digital audible biomarkers. Dr. Song has a Ph.D. in electrical and electronics engineering from Korea Advanced Institute of Science and Technology. She brings a wealth of experience to the show, having served previously as the Chief Operating Officer at HUINNO, a Boston Seoul-based digital health startup, and as a member of the digital health advisory committee at the Ministry of Food and Drug Safety for two years. She also spent over ten years as a Senior Strategic Operations Manager at Lam Research Corporation, a NASDAQ company and global leader in semiconductor equipment, and in various technology and product leadership roles in LG Electronics in the high technology and consumer electronics field.  Stay tuned to learn all you need to know about the innovative new proudP mobile app. Disclaimer: The Prostate Health Podcast is for informational purposes only. Nothing in this podcast should be construed as medical advice. By listening to the podcast, no physician-patient relationship has been formed. For more information and counseling, you must contact your personal physician or urologist with questions about your unique situation. Show Highlights: Dr. Song explains how AI detects subtle changes in urine flow and sound to measure flow speed and amount with proudP Dr. Song shares the story behind proudP The limitations of office-based uroflow practices The accuracy of the uroflow data captured with proudP Why objective data is essential for BPH treatments The implications for urologists of implementing the proudP technology within the urology space  Where can the proudP app be obtained? Links:  Get your free What To Expect Guide or find the link on our podcast website.  Join our Facebook group.  Follow Dr. Pohlman on Twitter and Instagram. (@gpohlmanmd) Go to the Prostate Health Academy to sign up.  You can access Dr. Pohlman's free mini webinar, where he discusses his top three tips to promote men's prostate health, longevity, and quality of life here. Soundable Health proudP

In the labyrinthine world of pharmaceuticals, ensuring the safety of drugs is a critical yet often overlooked aspect. Meet Kim Witczak, an international drug safety advocate and speaker hailing from Minneapolis, USA. Kim's journey is marked by personal tragedy turned into a tireless crusade for accountability and transparency in the pharmaceutical industry. In this conversation, we delve into Kim's insights, challenges, and victories in her quest for safer drugs and a more ethical pharmaceutical landscape. [00:31] - About Kim Witczak Kim is an International Drug Safety Advocate and Speaker. She was instrumental in helping to get the FDA black-box suicide warnings added to anti-depressants in 2004 and 2006. Kim is currently a consumer representative on the FDA Psychopharmacologic Drug Advisory Committee. She has been recognised and felicitated several times. --- Support this podcast: https://podcasters.spotify.com/pod/show/tbcy/support

In this episode, my guest, Kim Witczak, shares her personal story of how her husband's death by suicide led her to become an advocate for drug safety. Her husband Woody's sudden death was linked to an adverse reaction to antidepressant medication. Despite having no history of depression or mental illness, Woody was prescribed Zoloft for insomnia, which led to a tragic outcome.Kim's journey has taken her from personal tragedy to the forefront of healthcare reform. She played a pivotal role in getting the FDA to add black box suicide warnings to antidepressants and has tirelessly worked to raise public awareness about the flaws in our drug safety system through her organization, WoodyMatters.com.In our conversation, Kim emphasized the importance of transparency, accountability, and informed decision-making when it comes to medication. She challenges the narrative that life shouldn't be hard and questions the quick-fix culture that often leads to the overprescription of powerful drugs.Furthermore, Kim shares how her faith has provided her with strength and resilience throughout her advocacy journey. She's committed to reshaping the medical industry to prioritize people over profits.So, get ready to be inspired and take action. Tune in now and let's make a difference together!Chapters[00:00] - Podcast Episode Preview[01:07] - Introduction to Visibly Fit Podcast[01:49] - Pharmaceutical Commercials and Side Effects[03:00] - Kim's Background Story and Advocacy[06:16] - Kim Becomes an Accidental Advocate[09:17] - Woody's Adverse Reaction to Zoloft[11:02] - The Tragic Outcome of Woody's Medication[13:08] - Antidepressants and The Possible Link To Suicide[16:40] - FDA Approval Controversies[18:40] - Marketing and Lack of Transparency in the Pharmaceutical Industry[21:25] - Harm Caused by Medications and the Call for Accountability[25:27] - The Need for Advocates in Healthcare[29:25] - Kim's Faith and Grief Journey[33:10] - A Sign of Hope: The Floating Bible[39:55] - David vs. Goliath: Advocating for Change[42:54] - Encouragement to Share Personal Experiences for Change[44:12] - Unselling Sickness and Challenging the System[45:47] - Conclusion and Invitation to Visibly Fit Program[47:38] - Wrap-up and GratitudeResources mentioned:Woody Matters websiteSelling SicknessVisibly Fit 7-Week Accelerator ProgramConnect with today's guest:Kim Witczak is a leading global drug safety advocate and speaker with over 25 years of professional experience in advertising and marketing communications. She became involved in pharmaceutical drug safety issues after the sudden death of her husband due to the undisclosed drug side effects of an antidepressant. Kim co-founded Woodymatters, a non-profit dedicated to advocating for a stronger FDA and drug safety system. She co-created and organized the international, multi-disciplinary conference Selling Sickness: People Before Profits conference in Washington, D.C. In 2016, she was appointed Consumer Representative on the FDA Psychopharmacologic Drug Advisory Committee and is on the Board of Directors of the National Physicians Alliance and MISSD (Medication Induced Suicide Prevention in Memory of Stewart Dolin.) She is an active member of the DC-based Patient, Consumer, and Public Health Coalition making sure the voice of non-conflicted patients and consumers is represented in healthcare/FDA-related legislative issues....

Ana Barac, MD, PhD, and Laleh Amiri-Kordestani, MD, offer a unique perspective on the development and safety of novel therapeutics, with a focus on cardio-oncology.

In this podcast recorded in early March, James Cave (Editor-in-Chief) and David Phizackerley (Deputy Editor) talk about the April 2024 issue of DTB. They discuss the editorial that questions whether drug safety alerts are effective in changing practice and whether more needs to be done to implement safety recommendations (https://dtb.bmj.com/content/62/4/50). They review the Medicines and Healthcare products Regulatory Agency's latest risk minimisation measures for using valproate, which include a guide for healthcare professionals, a guide for patients, an annual risk acknowledgement form and an information card for patients (https://dtb.bmj.com/content/62/4/53). The main article considers the evidence for a new progestogen only pill containing drospirenone (https://dtb.bmj.com/content/62/4/55). They begin by discussing recent concerns over neuropsychiatric reactions associated with montelukast. Please subscribe to the DTB podcast to get episodes automatically downloaded to your mobile device and computer. Also, please consider leaving us a review or a comment on the DTB Podcast iTunes podcast page (https://podcasts.apple.com/gb/podcast/dtb-podcast/id307773309). If you want to contact us please email dtb@bmj.com. Thank you for listening.

 Join me as I speak to Psychiatrist, Author, and Professor at Emory University Dr. Doug Bremner. Dr. Bremner is a world leader in research in the field of (PTSD), Drug Safety and the Side Effects of Prescription Drugs. Welcome to Life With Peter G, the show where we explore the many facets of life through the lens of host Peter G's unique perspective. From business to relationships, personal growth to pop culture, Peter G takes us on a journey of discovery and self-reflection with each episode. With a combination of insightful interviews, engaging discussions, and personal anecdotes, Life With Peter G offers a fresh and authentic take on the human experience. Join us as we delve into the complexities and joys of life, one conversation at a time. This is Life With Peter G, The Peter G Show Every Wednesday Night. 6:00pm Pacific, 8:00pm Central, and 9:00pm Eastern. We're Talking About Things You Need To Hear. Check It Out. Don't forget to listen on the go with The Peter G Show On Audio Podcast Everywhere. And Please Like and Subscribe to The Peter G Show YouTube Channel. Love You Guys, Peace Out. @petergshow @dougbremner #petergshow,#subscribe,#like,#follow,#truth,#share,#world,#america,#love,#peace,#family,#problems,#money,#drdougbremner,#psychiatrist,#author,#ptsd,#drugsafety

ADHD IS A GENETIC ADVANTAGE is an episode with my guest Su Robotti, a Consumer Health Advocate and the founder of the MedShadow Foundation, launched in 2013. She did so after she was harmed by a medicine called DES (diethylstilbestrol) that was given to her mother while pregnant and as a result was unable to have children. Generations later, this hormone disruptor has been found to cause rare cancers, autoimmune diseases and infertility. In 2017 Robotti was appointed to the FDA Advisory Committee on Drug Safety and Risk Management, joining  a panel of doctors and pharmacists as the sole consumer representative. Together, the Committee reviews research and decides if a drug is safe enough for use. Su and I are going to do a deep dive on such topics as the risks of side effects from medicines; questions to ask your doctor about meds; increased risks of meds for children and the FDA's drug approval process in general as well as her role on the FDA Advisory Committee. Mentioned Links: https://www.desaction.org https://www.cochrane.org https://pubmed.ncbi.nlm.nih.gov https://newsarchive.berkeley.edu/news/media/releases/99legacy/5-5-1999.html https://medshadow.org/associates/suzanne-robotti/ For more information on this podcast, please visit www.adhdisover.com

Serious and unexpected adverse drug reactions – the ‘black swans' of pharmacovigilance – can place enormous strain on safety monitoring systems. Drawing examples from the COVID-19 pandemic, François Montastruc from Toulouse University Hospital explains how we can get better at dealing with the unpredictable.Tune in to find out:What Nassim Nicholas Taleb's ‘black swan' theory has to do with pharmacovigilanceWhat makes an adverse drug reaction a black, white, or grey swan Why flexibility and communication are key to patient safetyWant to know more?Here are the research articles cited in the episode:Quality of reporting of adverse events in clinical trials of COVID-19 drugs: systematic reviewPsychiatric disorders and hydroxychloroquine for COVID-19: a VigiBase studyHepatic disorders with the use of remdesivir for COVID-19Serious bradycardia and remdesivir for COVID-19: a new safety concernOxford-AstraZeneca COVID-19 vaccine-induced cerebral venous thrombosis and thrombocytopaenia: a missed opportunity for a rapid return of experienceAtypical thrombosis associated with VaxZevria® (AstraZeneca) vaccine: data from the French network of regional pharmacovigilance centresTeaching pharmacovigilance to French medical students during the COVID-19 pandemic: interest of distance learning clinical reasoning sessionsIf you enjoyed this podcast, check out these related episodes from the Drug Safety Matters archive:Reforming pharmacovigilance educationLessons in pandemic pharmacovigilanceIntuition in pharmacovigilanceJoin the conversation on social mediaFollow us on X, LinkedIn, or Facebook and share your thoughts about the show with the hashtag #DrugSafetyMatters.Got a story to share?We're always looking for new content and interesting people to interview. If you have a great idea for a show, get in touch!About UMCRead more about Uppsala Monitoring Centre and how we work to advance medicines safety.

The liver is the primary site for drug metabolism in the body, but it can be severely damaged by medicines or their toxic compounds. Rita Baião from the North Lisbon University Hospital Center reviews what pharmacovigilance professionals should know about drug-induced liver injury (DILI).Tune in to find out:Who is most at risk of developing DILIHow to diagnose the condition and control the damageHow to assess case reports of DILIWant to know more?This infographic in Nature Reviews nicely summarises the mechanisms, diagnosis, and management of drug-induced liver injury.In this report, the Council for International Organizations of Medical Sciences provides a global perspective on DILI detection, susceptibility factors, outcomes, and more.In this Drug Safety article, industry representatives outline how to identify, mitigate, and communicate the risk of DILI during drug development. The PRO-EURO DILI NETWORK coordinates research efforts on DILI across Europe and provides a forum to exchange knowledge and training on the topic. Similar initiatives include the Spanish DILI Registry and the Latin American DILI Network.The free online tool LiverTox contains up-to-date information on drug-induced liver injury for medicines and herbal products.To learn more about post-marketing surveillance and clinical care of DILI, check out Uppsala Monitoring Centre's free online course on the topic.For more on the clustering algorithm vigiGroup, revisit this interview with UMC scientists Jim Barrett and Joe Mitchell.Join the conversation on social mediaFollow us on X, LinkedIn, or Facebook and share your thoughts about the show with the hashtag #DrugSafetyMatters.Got a story to share?We're always looking for new content and interesting people to interview. If you have a great idea for a show, get in touch!About UMCRead more about Uppsala Monitoring Centre and how we work to advance medicines safety.

I divide Paxlovid, nirmatrelvir, and ritonavir into syllables, explain which syllables have the emphasis, and reveal the sources of my information.  The written pronunciations are below and on https://www.thepharmacistsvoice.com.  The purpose of my pronunciation episodes is to provide the intended pronunciations of drug names from reliable sources so you feel more confident saying them and less frustrated learning them.  Paxlovid = pax LO vid; emphasize LO.  Nirmatrelvir = NIR ma TREL vir; emphasize NIR and TREL.  TREL gets the most emphasis. Ritonavir = ri TON a vir; emphasize TON. Thank you for listening to episode 254 of The Pharmacist's Voice ® Podcast! To read the FULL show notes, visit https://www.thepharmacistsvoice.com/podcast.  Select episode 254. Subscribe to or follow The Pharmacist's Voice ® Podcast to get each new episode delivered to your podcast player and YouTube every time a new one comes out!   Apple Podcasts   https://apple.co/42yqXOG  Google Podcasts  https://bit.ly/3J19bws  Spotify  https://spoti.fi/3qAk3uY  Amazon/Audible  https://adbl.co/43tM45P YouTube https://bit.ly/43Rnrjt Links from this episode How to Pronounce Nirmatrelvir - YouTube (recommended by Pfizer Media Relations - 212-733-1226, pfizermediarelations@pfizer.com) Paxlovid package insert.  See patient information section (after section 17/pt counseling info) Pfizer website, Paxlovid pronounced (healthcare provider video) YouTube, Paxlovid direct-to-consumer commercial (published by Pfizer) USP Dictionary Online (aka “USAN”)  **Subscription-based resource USP Dictionary's (USAN) pronunciation guide (Free resource on the American Medical Association's website) The Pharmacist's Voice ® Podcast episode 250, pronunciation series episode 22 (metformin/Glucophage) The Pharmacist's Voice Podcast ® episode 245, pronunciation series episode 21 (naltrexone/Vivitrol) The Pharmacist's Voice ® Podcast episode 240, pronunciation series episode 20 (levalbuterol) The Pharmacist's Voice ® Podcast episode 236, pronunciation series episode 19 (phentermine)  The Pharmacist's Voice ® Podcast episode 228, pronunciation series episode 18 (ezetimibe) The Pharmacist's Voice ® Podcast episode 219, pronunciation series episode 17 (semaglutide) The Pharmacist's Voice ® Podcast episode 215, pronunciation series episode 16 (mifepristone and misoprostol) The Pharmacist's Voice ® Podcast episode 211, pronunciation series episode 15 (Humira®) The Pharmacist's Voice ® Podcast episode 202, pronunciation series episode 14 (SMZ-TMP) The Pharmacist's Voice ® Podcast episode 198, pronunciation series episode 13 (carisoprodol) The Pharmacist's Voice ® Podcast episode 194, pronunciation series episode 12 (tianeptine) The Pharmacist's Voice ® Podcast episode 188, pronunciation series episode 11 (insulin icodec)  The Pharmacist's Voice ® Podcast episode 184, pronunciation series episode 10 (phenytoin and isotretinoin) The Pharmacist's Voice ® Podcast episode 180, pronunciation series episode 9 Apretude® (cabotegravir) The Pharmacist's Voice ® Podcast episode 177, pronunciation series episode 8 (metoprolol)  The Pharmacist's Voice ® Podcast episode 164, pronunciation series episode 7 (levetiracetam) The Pharmacist's Voice ® Podcast episode 159, pronunciation series episode 6 (talimogene laherparepvec or T-VEC)  The Pharmacist's Voice ® Podcast episode 155, pronunciation series episode 5 Trulicity® (dulaglutide)  The Pharmacist's Voice ® Podcast episode 148, pronunciation series episode 4 Besponsa® (inotuzumab ozogamicin) The Pharmacist's Voice ® Podcast episode 142, pronunciation series episode 3 Zolmitriptan and Zokinvy The Pharmacist's Voice ® Podcast episode 138, pronunciation series episode 2 Molnupiravir and Taltz The Pharmacist's Voice ® Podcast episode 134, pronunciation series episode 1 Eszopiclone and Qulipta

The horseshoe crab has endured for over 450 million years. It has survived several mass extinctions including the one that killed off the dinosaurs. One reason for their incredible resiliency is their ability to fend off bacterial infection. Their blood contains cells that clot around invading bacteria, thereby protecting them from the attacking toxins.In this episode we talk with three experts about how this animal's unique blue blood has become essential to modern medicine. We also talk about why horseshoe crab populations are dwindling, and what biotech is doing to address the shortfall.Follow us on LinkedIn, X, Facebook and Instagram. Visit us at https://www.bio.org/

In this episode, our hosts are joined by Charles Ducker, PhD (NAMSA's Senior Director of Analytical Services) who recently returned from Korea, where he provided training to the MFDS (Ministry of Food and Drug Safety) about ISO 10993-18. Throughout this discussion, we review the use of the standard and how it is adopted by Korean authorities. We also explore the challenges that lie ahead for device developers and testing labs.“I think they [MFDS] were maybe surprised at the complexity. Laying out the information you have on your materials and the knowledge that you already have that may not lead to doing testing.” – Dr. Charles Ducker“They were interested in how to apply ISO 10993-1 and how you apply ISO 10993-18 to the standard. And they want to know how to assess whether a laboratory has conducted the test appropriately.” – Dr. Charles Ducker“One of the things I thought was very interesting… around Part 18, was what is different now versus the outdated version, and what changes came about. We had a lot of discussion about what is required and one of the big ones was AET [Analytical Evaluation Threshold] and how we calculate it.” – Dr. Charles Ducker“Also, about how we qualify methods, what components go into that and what data you have to have behind the scenes to support the fact that your methods are appropriate for the intended use.” – Dr. Charles DuckerTopics include:Korea's current position with the use of ISO 10993-18Qualification of a laboratory for chemical characterization testingSolvents and temperatures, and the justifications for each

To mark #MedSafetyWeek, which took place from 6–12 November, we're releasing a special two-part episode on pharmacovigilance communication campaigns. In this second part, we hear from three #MedSafetyWeek veterans – Anne-Cécile Vuillemin from the Ministry of Health in Luxembourg, Ban Al-Shimran from the Iraqi Ministry of Health, and Frieda Shigwedha from the Therapeutic Information and Pharmacovigilance Centre in Namibia – about what makes a successful campaign.Tune in to find out:Why you should always tailor your communication strategy to your settingHow to deal with the financial, cultural, and logistical challenges of campaign planningWhat to keep in mind if you are new to #MedSafetyWeekWant to know more?You can read a summary of this episode on the Uppsala Reports news site.To learn more about #MedSafetyWeek, check out the hashtag online and visit the campaign website, where you will also find free social media materials in several languages.This is the second of a two-part episode on pharmacovigilance communication campaigns. Listen to the first part here.Join the conversation on social mediaFollow us on Twitter, Facebook or LinkedIn and share your thoughts about the show with the hashtag #DrugSafetyMatters.Got a story to share?We're always looking for new content and interesting people to interview. If you have a great idea for a show, get in touch!About UMCRead more about Uppsala Monitoring Centre and how we work to advance medicines safety.

Today on Midday, it's the Midday Healthwatch with Dr. Leana Wen. This week Tom talks with Dr. Wen about Paxlovid and any precautions people should take as we move toward the Thanksgiving holiday. They also discuss the pros and cons of using Ozempic for weight loss.Email us at midday@wypr.org, tweet us: @MiddayWYPR, or call us at 410-662-8780.

To mark #MedSafetyWeek, which takes place from 6–12 November, we're releasing a special two-part episode on pharmacovigilance communication campaigns. In this first part, we speak to Mitul Jadeja from the Medicines and Healthcare products Regulatory Agency in the UK about under-reporting and how initiatives like #MedSafetyWeek can help draw attention to medicines safety.Tune in to find out:Why under-reporting plagues all pharmacovigilance systemsWhat regulators can do to encourage people to report side effectsWhy we need reports from both patients and healthcare professionalsWant to know more? Here are the studies cited in the episode:A BMJ study in 2022 measured the burden and associated cost of adverse drug reactions, polypharmacy and multimorbidity at a hospital in the UK.In 1976, Inman proposed a theoretical model, known as the ‘seven deadly sins', to explain why healthcare professionals fail to report adverse drug reactions. This recent systematic review in Drug Safety expands on that. The SCOPE Joint Action project aimed to enhance pharmacovigilance in the EU and delivered practical guidance for regulators.The first UK study to compare Yellow Card reports from patients and healthcare professionals was published in 2012.To join the #MedSafetyWeek campaign next week, follow the hashtag online and check out the campaign website for free social media materials.Finally, don't forget to tune in on 13 November for part 2 of this podcast, where we'll hear from #MedSafetyWeek advocates in Iraq, Luxembourg, and Namibia about their experience with the campaign. Read a preview of the conversation on Uppsala Reports.Join the conversation on social mediaFollow us on Twitter, Facebook or LinkedIn and share your thoughts about the show with the hashtag #DrugSafetyMatters.Got a story to share?We're always looking for new content and interesting people to interview. If you have a great idea for a show, get in touch!About UMCRead more about Uppsala Monitoring Centre and how we work to advance medicines safety.

The FDA Group's CEO, Nick Capman, sits down with Steve Knowles, MB.BS, M.R.C.P., M.F.P.M., Chief Medical Officer at Halozyme, a biopharmaceutical company bringing disruptive solutions to significantly improve patient experiences and outcomes for emerging and established therapies. They discuss advancements in drug delivery technology and the role of leadership in fostering innovation and addressing challenges in this field. Discussion points include: » Dr. Knowles's transition from a physician in the UK to Chief Medical Officer at Halozyme in San Diego. » The evolution in drug delivery systems, such as the shift from hospital-based treatments to self-administration of drugs at home and the introduction of auto-injectors and on-body devices for efficient, patient-friendly drug administration. » Addressing human factors and compliance to ensure products are user-friendly—and the importance of human factor studies in product development. » The advantages of subcutaneous drug delivery, including reduced side effects, improved pharmacokinetic profiles, and patient convenience. » How Halozyme's one-team approach fosters a culture of curiosity, flexibility, and feedback. » Aligning individual and organizational goals to drive innovation. Dr. Knowles has deep pharmacovigilance and medical affairs experience gained over a career spanning almost 20 years. Dr. Knowles joined Halozyme in January 2018 as Vice President, Drug Safety & Pharmacovigilance. He is responsible for the Medical, Regulatory and Drug Safety organizations. Prior to Halozyme, Dr. Knowles served as Senior Medical Director, Global Patient Safety and Benefit Risk Management at Eli Lilly & Co. where he led the global safety physician/scientist group responsible for overseeing the safety profiles and benefit risk management of medicines across all therapeutic areas and phases of development and supported numerous BLA and MAA submissions. During his 16 years at Lilly, he held positions in Medical Affairs and from 2005 to 2017 he held roles of increasing responsibility within Global Patient Safety. Prior to these roles, Dr. Knowles spent more than 17 years in clinical practice in the UK in both hospital-based and general practice roles. Dr. Knowles received his Bachelor of Medicine and Surgery degrees (MB.BS) from the University of Newcastle Upon Tyne and is a Member of the Royal College of Physicians (MRCP) and a Member of the Faculty of Pharmaceutical Medicine (MFPM). Who is The FDA Group? The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus in Quality Assurance, Regulatory Affairs, and Clinical Operations. https://www.thefdagroup.com/

Do you want to hear a story about a crime-fighting pharmacist? This episode has it! This month's VIP (very important person), Shabbir Safdar, has served as the Executive Director of the Partnership for Safe Medicines since 2017. He shares some incredible information about drug safety and supply chain security, an update on importing medication from Canada, and the fight against counterfeit drugs. Also, hear an amazing story about a pharmacist in Texas who actually caught and stopped a ring of counterfeit HIV medicines. Upcoming NPA Events: October 5-7 - Virtual Fall Pharmacy Forum October 10 - AE Tour - Wayne October 11 - Resident Student Happy Hour! October 26 - Nebraska Pharmacy Foundation Fundraiser: Charcuterie Workshop November 2 - ACE Tour - Gretna November 4 - NPA Tailgate November 11 - ACE Tour - Beatrice   Partnership For Safe Medicines Links: Website | Info for Pharmacists | TikTok | YouTube | Shabbir Safdar ___ Connect with the Pharm Girls | Facebook | Instagram | LinkedIn To learn more about Nebraska Pharmacy Association visit https://www.npharm.org/

TODAY ON THE ROBERT SCOTT BELL SHOW: Jonathan Emord, Open border crisis, Fetterman dress code, Constitutional confusion, Chicago crime fiasco, National debt record, Rogue FDA, Health Freedom victory, Vaccine hesitancy studies, Kim Witczak, Selling sickness, Drug safety, FDA accountability, Homeopathic Hit – Sulphur and MORE! http://www.robertscottbell.com/natural-remedies/jonathan-emord-open-border-crisis-fetterman-dress-code-constitutional-confusion-chicago-crime-fiasco-national-debt-record-rogue-fda-health-freedom-victory-vaccine-hesitancy-studies-kim-witcza/

Follow us on LinkedIn, X, Facebook and Instagram. Visit us at https://www.bio.org/The horseshoe crab has endured for over 450 million years. It has survived several mass extinctions including the one that killed off the dinosaurs. One reason for their incredible resiliency is their ability to fend off bacterial infection. Their blood contains cells that clot around invading bacteria, thereby protecting them from the attacking toxins.In this episode we talk with three experts about how this animal's unique blue blood has become essential to modern medicine. We also talk about why horseshoe crab populations are dwindling, and what biotech is doing to address the shortfall.

Fear of medications and their side effects is a major reason why many people don't take their arthritis meds as prescribed, but it's not the only one. Learn more about some reasons people skip doses or don't take their meds, why that's a bad idea, and hear ways to feel more confident and able to stick with your meds. This episode was brought to you in part by AbbVie, Bristol Myers Squibb, Janssen and Kenvue. Visit the Live Yes! With Arthritis Podcast episode page get show notes, additional resources and read the full transcript: https://bit.ly/LiveYes_Ep84 We want to hear from you. Tell us what you think about the Live Yes! With Arthritis Podcast. Get started by emailing podcast@arthritis.org. Special Guest: Elizabeth Salt, PhD, APRN .

***Sensitive content. Viewer Discretion Advised.*** Help is available, speak with someone today Suicide and Crisis Lifeline Dial 988 - www.988lifeline.org On this Episode 364 of Health Solutions, Shawn & Janet Needham R. Ph. talk to Kim Witczak about drug safety advocacy. Kim discusses Zoloft suicide story, how the FDA works, and antidepressants. 00:00 ~ Start 00:22 ~ Introduction 01:32 ~ Zoloft suicide story 08:08 ~ Becoming an advocate 12:39 ~ Big Pharma 16:36 ~ How the FDA works 20:29 ~ Disease states & funding 32:54 ~ Antidepressants & covid vaccines 38:18 ~ Informed consent 43:27 ~ Censorship 50:30 ~ Advisory board 55:45 ~ Contact Kim Witczak 58:31 ~ Closing comments Episode Resources Instagram ~ https://www.instagram.com/kim_witczak Twitter ~ https://twitter.com/woodymatters LinkedIn ~ https://www.linkedin.com/in/kimwitczak Website ~ www.kimwitczak.com Website ~ www.woodymatters.com EP 364: Kim Witczak on Drug Safety Advocacy with Shawn & Janet Needham R. Ph. of MLRX WA ~ #depression #drugsafety #sellingsickness #antidepressants #bigpharma #FDA #suicideprevention #suicideawareness #podcastshow #optimalhealth #healthfreedom #medicalcare #HealthCare #PriceTransparency #freemarket #Liberty #FitAfter50 #FitOver50 #fitover40 #fitafter40 #Boise #IdahoFalls #Tricities #SiouxFalls #Wenatchee #EducateAndEmpower #NeedhamHealthSolutions #TeamNeedham #ShawnNeedham #HealthSolutions #MosesLakeProfessionalPharmacy #MLRX #SickenedTheBook #ShawnNeedhamRPh #ThinkOutsideTheSystem #OptimalHealthMatters #ItsTime ~ *** #BenShapiro & #DaveRamsey Fans. Learn how to be in the driver's seat for your healthcare choices {not the system or doctors!}

Ebro, Rosenberg and Laura Stylez star in HOT97's flagship program Ebro in the Morning - this episode aired on 6/9/2023. Get tickets with Gametime: https://gametime.co/  Ebro, Rosenberg, Laura Stylez and the crew are broadcasting live from HOT 97 - talking about the the aliens landing in Vegas, drug safety, and so much more! Find New HOT 97 Podcasts: https://www.hot97.com/podcasts See omnystudio.com/listener for privacy information.

In this week's show, Dr. Kerri Best-Sule describes how she discovered early in her clinical career that traditional medical practice does not support healthy family life. She completed her pediatric residency at the University of Maryland and then went on to practice outpatient pediatrics for 3 years before deciding to make her transition into the pharma industry. She started by working as a contracted part-time employee before deciding to move full-time into a role in Pharma Safety involving vaccines. Her temporary position helped greatly in making the transition from clinical work to Pharma Safety Associate Medical Director. During our conversation, she offers her advice for those wishing to pursue a similar career path. You will find all of the links mentioned in the episode at https://nonclinicalphysicians.com/drug-safety-professional/                                                            =============== You can support this podcast by making a small monthly or annual donation. To learn more, go to nonclinicalphysicians.com/donate You can now join the most comprehensive Community for all clinicians looking for a nontraditional career at NewScr!pt. Get an updated edition of the FREE GUIDE to 10 Nonclinical Careers at nonclinicalphysicians.com/freeguide. Get a list of 70 nontraditional jobs at nonclinicalphysicians.com/70jobs. Check out a FREE WEBINAR called Best Options for an Interesting and Secure Nonclinical Job at nonclinicalphysicians.com/freewebinar1