FDA adds Boxed Warning for increased risk of severe hypocalcemia in patients with advanced chronic kidney disease taking osteoporosis medicine Prolia (denosumab)
Listen to FDA Drug Safety Podcast titled, FDA adds Boxed Warning for increased risk of severe hypocalcemia in patients with advanced chronic kidney disease taking osteoporosis medicine Prolia (denosumab). (Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - February 6, 2024 Category: Drugs & Pharmacology Authors: U.S. Food and Drug Administration, Center for Drug Evaluation and Research Source Type: podcasts
Update on FDA ’s ongoing evaluation of reports of suicidal thoughts or actions in patients taking a certain type of medicines approved for type 2 diabetes and obesity
Listen to FDA Drug Safety Podcast, FDA's preliminary evaluation has not found evidence that use of GLP-1 RAs causes suicidal thoughts/actions. (Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - January 26, 2024 Category: Drugs & Pharmacology Authors: U.S. Food and Drug Administration, Center for Drug Evaluation and Research Source Type: podcasts
FDA warns of rare but serious drug reaction to the antiseizure medicines levetiracetam (Keppra, Keppra XR, Elepsia XR, Spritam) and clobazam (Onfi, Sympazan)
Listen to an audio podcast of the November 28, 2023, FDA Drug Safety Communication, FDA warns of rare but serious drug reaction to the antiseizure medicines levetiracetam (Keppra, Keppra XR, Elepsia XR, Spritam) and clobazam (Onfi, Sympazan). (Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - December 8, 2023 Category: Drugs & Pharmacology Authors: U.S. Food and Drug Administration, Center for Drug Evaluation and Research Source Type: podcasts
FDA updating warnings to improve safe use of prescription stimulants used to treat ADHD and other conditions
Listen to an audio podcast of the May 11, 2023, FDA Drug Safety Communication on warnings to improve safe use of prescription stimulants used to treat ADHD and other conditions (Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - May 31, 2023 Category: Drugs & Pharmacology Authors: U.S. Food and Drug Administration, Center for Drug Evaluation and Research Source Type: podcasts
FDA updates prescribing information for all opioid pain medicines to provide additional guidance for safe use
Listen to an audio podcast of the April 13, 2023, FDA Drug Safety Communication, FDA updates prescribing information for all opioid pain medicines to provide additional guidance for safe use. (Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - May 10, 2023 Category: Drugs & Pharmacology Authors: U.S. Food and Drug Administration, Center for Drug Evaluation and Research Source Type: podcasts
FDA investigating risk of severe hypocalcemia in patients on dialysis receiving osteoporosis medicine Prolia (denosumab)
(Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - December 16, 2022 Category: Drugs & Pharmacology Authors: U.S. Food and Drug Administration, Center for Drug Evaluation and Research Source Type: podcasts
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
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
