- by U.S. Food and Drug Administration, Center for Drug Evaluation and ResearchSerious liver injury being observed in patients without cirrhosis taking Ocaliva (obeticholic acid) to treat primary biliary cholangitis
- by U.S. Food and Drug Administration, Center for Drug Evaluation and ResearchListen to an audio podcast of the September 12th, 2024 FDA Drug Safety Communication on rare occurrence of serious liver injury with use of Veozah (fezolinetant) for hot flashes due to menopause.
- by U.S. Food and Drug Administration, Center for Drug Evaluation and ResearchListen 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).
- by U.S. Food and Drug Administration, Center for Drug Evaluation and ResearchListen to FDA Drug Safety Podcast, FDA's preliminary evaluation has not found evidence that use of GLP-1 RAs causes suicidal thoughts/actions.
- by U.S. Food and Drug Administration, Center for Drug Evaluation and ResearchListen 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).
- by U.S. Food and Drug Administration, Center for Drug Evaluation and ResearchListen 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
- by U.S. Food and Drug Administration, Center for Drug Evaluation and ResearchListen 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.
- by U.S. Food and Drug Administration, Center for Drug Evaluation and ResearchFDA investigating risk of severe hypocalcemia in patients on dialysis receiving osteoporosis medicine Prolia (denosumab)
- by U.S. Food and Drug Administration, Center for Drug Evaluation and ResearchListen 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.
- by U.S. Food and Drug Administration, Center for Drug Evaluation and ResearchListen 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)
- by U.S. Food and Drug Administration, Center for Drug Evaluation and ResearchListen to an audio podcast of the March 30, 2022 FDA Drug Safety Communication Iodinated Contrast Media
- by U.S. Food and Drug Administration, Center for Drug Evaluation and ResearchListen 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.
- by U.S. Food and Drug Administration, Center for Drug Evaluation and ResearchListen 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.
- by U.S. Food and Drug Administration, Center for Drug Evaluation and Research“Listen to FDA Drug Podcast, FDA warns that getting alcohol-based hand sanitizer in the eyes can cause serious injury
- by U.S. Food and Drug Administration, Center for Drug Evaluation and ResearchListen 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.
- by U.S. Food and Drug Administration, Center for Drug Evaluation and ResearchListen 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
- by U.S. Food and Drug Administration, Center for Drug Evaluation and ResearchListen 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"
- by U.S. Food and Drug Administration, Center for Drug Evaluation and ResearchListen 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
- by U.S. Food and Drug Administration, Center for Drug Evaluation and ResearchListen 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.
- by U.S. Food and Drug Administration, Center for Drug Evaluation and ResearchListen 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.