FDA warns that abuse and misuse of the OTC nasal decongestant propylhexedrine can lead to serious harm
Listen to an audio podcast of the March 25, 2021 FDA Drug Safety Communication warning that abuse and misuse of the over the counter (OTC) nasal decongestant propylhexedrine (brand name Benzedrex) can lead to serious harm such as heart and mental health problems. (Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - March 29, 2021 Category: Drugs & Pharmacology Authors: U.S. Food and Drug Administration, Center for Drug Evaluation and Research Source Type: podcasts

Coronavirus Vaccine Update With Paul Offit – February 11, 2021
Paul A. Offit, MD, of The Children's Hospital of Philadelphia returns to JAMA's Q&A series to provide an update on the emergence of COVID-19 variants and their implications for vaccine development, including the Johnson & Johnson vaccine, scheduled for a US Food and Drug Administration VRBPAC hearing on February 26, 2021. Recorded February 11, 2021. Related Article: SARS-CoV-2 Vaccines and the Growing Threat of Viral Variants (Source: JAMA Author Interviews)
Source: JAMA Author Interviews - February 15, 2021 Category: General Medicine Authors: JAMA Network Source Type: podcasts

Initial safety trial results find increased risk of serious heart-related problems and cancer with arthritis and ulcerative colitis medicine Xeljanz, Xeljanz XR (tofacitinib)
Listen to FDA Drug Safety Podcast on Drug Safety Communication titled "Initial safety trial results find increased risk of serious heart-related problems and cancer with tofacitinib (Xeljanz, Xeljanz XR) (Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - February 8, 2021 Category: Drugs & Pharmacology Authors: U.S. Food and Drug Administration, Center for Drug Evaluation and Research U.S. Food and Drug Administration, Center for Drug Evaluation and Research Source Type: podcasts

FDA Drug Safety Podcast: FDA warns about the risk of hepatitis B reactivating in some patients treated with direct-acting antivirals for hepatitis C
(Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - January 27, 2021 Category: Drugs & Pharmacology Authors: U.S. Food and Drug Administration, Center for Drug Evaluation and Research U.S. Food and Drug Administration, Center for Drug Evaluation and Research Source Type: podcasts

FDA Drug Safety Podcast: FDA revises description of mental health side effects of stop-smoking medicines Chantix and Zyban to reflect clinical trial findings
(Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - January 27, 2021 Category: Drugs & Pharmacology Authors: U.S. Food and Drug Administration, Center for Drug Evaluation and Research U.S. Food and Drug Administration, Center for Drug Evaluation and Research Source Type: podcasts

Coronavirus Vaccine Update With Arnold S. Monto, MD
Arnold S. Monto, MD, chaired the US Food and Drug Administration's Vaccines and Related Biological Products Advisory Committee (VRBPAC) meetings in December that led to Emergency Use Authorization (EUA) of the Pfizer/BioNTech and Moderna vaccines. He joins JAMA's Q&A series from the University of Michigan School of Public Health to discuss experience to date with the 2 products and what's next in vaccine development. Recorded January 11, 2021. Related Article(s): Experts Discuss COVID-19: Vaccine Allocation, Placebo Groups, and More (Source: JAMA Author Interviews)
Source: JAMA Author Interviews - January 14, 2021 Category: General Medicine Authors: JAMA Network Source Type: podcasts

Coronavirus Vaccine FDA Update
Peter W. Marks, MD, PhD, and Stephen M. Hahn, MD, return to JAMA's Q&A series to discuss the Pfizer/BioNTech and Moderna vaccines: the data, the weekend's EUA designation (Pfizer/BioNTech), and the process for future full licensure and postmarketing safety surveillance. Dr Marks directs the US FDA's Center for Biologics Evaluation and Research (CBER). Dr Hahn is commissioner of the US Food and Drug Administration. Recorded December 14, 2020. Related Article(s): Behaviorally Informed Strategies for a National COVID-19 Vaccine Promotion Program (Source: JAMA Author Interviews)
Source: JAMA Author Interviews - December 16, 2020 Category: General Medicine Authors: JAMA Network Source Type: podcasts

FDA recommends avoiding use of NSAIDs in pregnancy at 20 weeks or later because they can result in low amniotic fluid
Listen to an audio podcast of the October 15, 2020 FDA Drug Safety Communication titled "FDA recommends avoiding use of NSAIDs in pregnancy at 20 weeks or later because they can result in low amniotic fluid. This issue affects all NSAIDs availbale by prescription and over-the-counter (OTC)." (Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - October 22, 2020 Category: Drugs & Pharmacology Authors: U.S. Food and Drug Administration, Center for Drug Evaluation and Research U.S. Food and Drug Administration, Center for Drug Evaluation and Research Source Type: podcasts

FDA clinical trial protection failures, and an AI that can beat curling ’s top players
Investigative journalist Charles Piller joins host Sarah Crespi to discuss his latest Science exclusive: a deep dive into the Food and Drug Administration’s protection of human subjects in clinical trials. Based on months of data analysis and interviews, he uncovered long-term failures in safety enforcement in clinical trials and potential problems with trial data used to make decisions about drug and device approvals. Sarah also talks with Klaus-Robert Müller, a professor of machine learning at the Technical University of Berlin, about an artificial intelligence (AI) trained in the sport of curling—often...
Source: Science Magazine Podcast - October 1, 2020 Category: Science Authors: Science Magazine Source Type: podcasts

FDA clinical trial failures, and an AI that can beat curling ’s top players
Investigative journalist Charles Piller joins host Sarah Crespi to discuss his latest Science exclusive: a deep dive into the Food and Drug Administration ’s protection of human subjects in clinical trials. Based on months of data analysis and interviews, he uncovered long-term failures in safety enforcement in clinical trials and potential problems with trial data used to make decisions about drug and device approvals. Sarah also talks with Klaus- Robert Müller, a professor of machine learning at the Technical University of Berlin, about an artificial intelligence (AI) trained in the sport of curling—often described...
Source: Science Magazine Podcast - October 1, 2020 Category: Science Authors: Science Tags: Scientific Community Source Type: podcasts

FDA clinical trial failures, and an AI that can beat curling ’s top players
Investigative journalist Charles Piller joins host Sarah Crespi to discuss his latest Science exclusive: a deep dive into the Food and Drug Administration ’s protection of human subjects in clinical trials. Based on months of data analysis and interviews, he uncovered long-term failures in safety enforcement in clinical trials and potential problems with trial data used to make decisions about drug and device approvals. Sarah also talks with Klaus -Robert Müller, a professor of machine learning at the Technical University of Berlin, about an artificial intelligence (AI) trained in the sport of curling—often describe...
Source: Science Magazine Podcast - September 30, 2020 Category: Science Authors: Science Tags: Scientific Community Source Type: podcasts

FDA warns about serious problems with high doses of the allergy medicine diphenhydramine (Benadryl)
Listen to FDA Drug Safety Podcast on Drug Safety Communication titled "FDA warns about serious Problems with high doses of the allergy medicine diphenhydramine (Bendaryl). (Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - September 29, 2020 Category: Drugs & Pharmacology Authors: U.S. Food and Drug Administration, Center for Drug Evaluation and Research U.S. Food and Drug Administration, Center for Drug Evaluation and Research Source Type: podcasts