FDA Drug Safety Podcasts

FDA investigating risk of severe hypocalcemia in patients on dialysis receiving osteoporosis medicine Prolia (denosumab)

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

FDA withdrew its approval for the cancer medicine Ukoniq (umbralisib) due to safety concerns

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

FDA recommends thyroid monitoring in babies and young children who receive injections of iodine-containing contrast media for medical imaging

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

FDA investigating possible increased risk of death with lymphoma medicine Ukoniq (umbralisib)

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

FDA warns about dental problems with buprenorphine medicines dissolved in the mouth to treat opioid use disorder and pain

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

FDA warns that getting alcohol-based hand sanitizer in the eyes can cause serious injury

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

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

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

FDA requests removal of strongest warning against using cholesterol-lowering statins during pregnancy; still advises most pregnant patients should stop taking statins

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

FDA warns that vapors from alcohol-based hand sanitizers can have side effects

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

Due to risk of serious liver injury, FDA restricts use of obeticholic acid (Ocaliva) in primary biliary cholangitis (PBC) patients with advanced cirrhosis

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

Studies show increased risk of heart rhythm problems with seizure and mental health medicine lamotrigine (Lamictal) in patients with heart disease

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

FDA warns that abuse and misuse of the OTC nasal decongestant propylhexedrine can lead to serious harm

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

Initial safety trial results find increased risk of serious heart-related problems and cancer with arthritis and ulcerative colitis medicine Xeljanz, Xeljanz XR (tofacitinib)

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

FDA recommends avoiding use of NSAIDs in pregnancy at 20 weeks or later because they can result in low amniotic fluid

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

FDA warns about serious problems with high doses of the allergy medicine diphenhydramine (Benadryl)

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

FDA requiring Boxed Warning updated to improve safe use of benzodiazepine drug class

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

FDA removes Boxed Warning about risk of leg and foot amputations for the diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR)

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

FDA recommends health care professionals discuss naloxone with all patients when prescribing opioid pain relievers or medicines to treat opioid use disorder

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

FDA cautions against use of hydroxychloroquine or chloroquine for COVID-19 outside of the hospital setting or a clinical trial due to risk of heart rhythm problems

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

FDA requests the withdrawal of the weight-loss drug Belviq, Belviq XR (lorcaserin) from the market

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

FDA strengthens warning that untreated constipation caused by schizophrenia medicine clozapine (Clozaril) can lead to serious bowel problems

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

Safety clinical trial shows possible increased risk of cancer with weight-loss medicine Belviq, Belviq XR (lorcaserin)

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

FDA warns about serious breathing problems with seizure and nerve pain medicines gabapentin (Neurontin, Gralise, Horizant) and pregabalin (Lyrica, Lyrica CR)

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

FDA warns about rare occurrence of serious liver injury with use of hepatitis C medicines Mavyret, Zepatier, and Vosevi in some patients with advanced liver disease

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

FDA approves Boxed Warning about increased risk of blood clots and death with higher dose of arthritis and ulcerative colitis medicine tofacitinib (Xeljanz, Xeljanz XR)

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

FDA identifies harm reported from sudden discontinuation of opioid pain medicines and requires label changes to guide prescribers on gradual, individualized tapering

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

Safety trial finds risk of blood clots in the lungs and death with higher dose of tofacitinib (Xeljanz, Xeljanz XR) in rheumatoid arthritis patients; FDA to investigate

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

FDA warns that symptoms of a serious condition affecting the blood cells are not being recognized with the leukemia medicine Idhifa (enasidenib)

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

FDA warns about rare but serious risks of stroke and blood vessel wall tears with multiple sclerosis drug Lemtrada (alemtuzumab)

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

FDA adds Boxed Warning for increased risk of death with gout medicine Uloric (febuxostat)

U.S. Food and Drug Administration, Center for Drug Evaluation and Research