FDA warns about possible increased risk of death and serious side effects with cancer drug Copiktra (duvelisib)
Listen to an audio podcast of the June 30, 2022, FDA Drug Safety Communication. Results from a clinical trial show a possible increased risk of death with Copiktra (active ingredient duvelisib) compared to another medicine to treat leukemia and lymphoma. (Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - July 27, 2022 Category: Drugs & Pharmacology Authors: U.S. Food and Drug Administration, Center for Drug Evaluation and Research Source Type: podcasts

FDA withdrew its approval for the cancer medicine Ukoniq (umbralisib) due to safety concerns
Listen to an audio podcast of the 6/1/22 for Ukoniq . FDA withdrew its approval for the cancer medicine Ukoniq (active ingredient umbralisib) due to safety concerns. Ukoniq was approved to treat two specific types of lymphoma: marginal zone lymphoma (MZL) and follicular lymphoma (FL) (Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - July 7, 2022 Category: Drugs & Pharmacology Authors: U.S. Food and Drug Administration, Center for Drug Evaluation and Research Source Type: podcasts

Coronapod: USA authorises vaccines for youngest of kids
After a long wait, the US Food and Drug Administration (FDA) and Centres for Disease Control and Prevention (CDC) have finally approved two COVID vaccines for use in children between the ages of six months and five years old. But despite a unanimous decision amongst regulators, parents still have questions about whether to vaccinate their young children, with survey data suggesting that the majority do not intend to accept vaccines right away. In this episode of Coronapod, we dig into the trials, the statistics and the regulators decision making process, in search of clarity around what the data are saying.News:&...
Source: Nature Podcast - June 24, 2022 Category: Science Authors: Springer Nature Limited Source Type: podcasts

Q & A With FDA Commissioner Robert Califf
After serving as commissioner of the US Food and Drug Administration (FDA) under President Obama, Robert M. Califf, MD, recently returned to the role, overseeing a critical federal agency that regulates food, drugs, therapeutics, and medical devices in the US. In a wide-ranging discussion with JAMA Deputy Editor Gregory Curfman, MD, Califf discusses COVID-19 vaccine modifications, the FDA’s approach to evaluating evidence, and efforts to combat health misinformation. Recorded April 26, 2022. Related Content: (Source: JAMA Author Interviews)
Source: JAMA Author Interviews - May 4, 2022 Category: General Medicine Authors: JAMA Network Source Type: podcasts

FDA recommends thyroid monitoring in babies and young children who receive injections of iodine-containing contrast media for medical imaging
Listen to an audio podcast of the March 30, 2022 FDA Drug Safety Communication Iodinated Contrast Media (Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - April 13, 2022 Category: Drugs & Pharmacology Authors: U.S. Food and Drug Administration, Center for Drug Evaluation and Research Source Type: podcasts

FDA investigating possible increased risk of death with lymphoma medicine Ukoniq (umbralisib)
Listen to an audio podcast of the February 3, 2022, FDA Drug Safety Communication, FDA is investigating a possible increased risk of death with the cancer medicine Ukoniq (umbralisib). We are re-evaluating this risk against the benefits of Ukoniq for its approved uses. (Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - February 9, 2022 Category: Drugs & Pharmacology Authors: U.S. Food and Drug Administration, Center for Drug Evaluation and Research Source Type: podcasts

FDA warns about dental problems with buprenorphine medicines dissolved in the mouth to treat opioid use disorder and pain
Listen to an audio podcast of the January 12, 2022, FDA Drug Safety Communication warning that dental problems have been reported with medicines containing buprenorphine that are dissolved in the mouth. (Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - January 24, 2022 Category: Drugs & Pharmacology Authors: U.S. Food and Drug Administration, Center for Drug Evaluation and Research Source Type: podcasts

FDA warns that getting alcohol-based hand sanitizer in the eyes can cause serious injury
“Listen to FDA Drug Podcast, FDA warns that getting alcohol-based hand sanitizer in the eyes can cause serious injury (Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - November 9, 2021 Category: Drugs & Pharmacology Authors: U.S. Food and Drug Administration, Center for Drug Evaluation and Research Source Type: podcasts

FDA requires warnings about increased risk of serious heart-related events, cancer, blood clots, and death for JAK inhibitors that treat certain chronic inflammatory conditions
Listen to an audio podcast of the September 1, 2021 FDA Drug Safety Communication on requiring revisions to the Boxed Warning for Xeljanz/Xeljanz XR, Olumiant, and Rinvoq to include information about the risks of serious heart-related events, cancer, blood clots, and death. (Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - September 8, 2021 Category: Drugs & Pharmacology Authors: U.S. Food and Drug Administration, Center for Drug Evaluation and Research Source Type: podcasts

FDA requests removal of strongest warning against using cholesterol-lowering statins during pregnancy; still advises most pregnant patients should stop taking statins
Listen to an audio podcast of the July 20, 2021 FDA Drug Safety Communication, FDA requests removal of strongest warning against using cholesterol-lowering statins during pregnancy; still advises most pregnant patients should stop taking statins (Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - July 22, 2021 Category: Drugs & Pharmacology Authors: U.S. Food and Drug Administration, Center for Drug Evaluation and Research Source Type: podcasts

FDA warns that vapors from alcohol-based hand sanitizers can have side effects
Listen to an audio podcast of the June 16, 2021 Drug Safety Communication "FDA warns that vapors from alcohol-based hand sanitizers can cause symptoms such as headache, nausea, and dizziness after applying to the skin" (Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - June 21, 2021 Category: Drugs & Pharmacology Authors: U.S. Food and Drug Administration, Center for Drug Evaluation and Research Source Type: podcasts

Due to risk of serious liver injury, FDA restricts use of obeticholic acid (Ocaliva) in primary biliary cholangitis (PBC) patients with advanced cirrhosis
Listen to FDA Drug Safety Podcast on due to risk of serious liver injury, FDA restricts use of Ocaliva in primary biliary cholangitis (PBC) patients with advanced cirrhosis (Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - June 3, 2021 Category: Drugs & Pharmacology Authors: U.S. Food and Drug Administration, Center for Drug Evaluation and Research Source Type: podcasts

Studies show increased risk of heart rhythm problems with seizure and mental health medicine lamotrigine (Lamictal) in patients with heart disease
Listen to an audio podcast of the March 31, 2021 FDA Drug Safety Communication that FDA review of studies show a potential increased risk of heart rhythm problems, in patients with heart disease taking lamotrigine (Lamictal). FDA requiring studies to evaluate heart risk across the drug class. (Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - April 2, 2021 Category: Drugs & Pharmacology Authors: U.S. Food and Drug Administration, Center for Drug Evaluation and Research Source Type: podcasts