Serious liver injury being observed in patients without cirrhosis taking Ocaliva (obeticholic acid) to treat primary biliary cholangitis

FDA adds warning about rare occurrence of serious liver injury with use of Veozah (fezolinetant) for hot flashes due to menopause

FDA adds Boxed Warning for increased risk of severe hypocalcemia in patients with advanced chronic kidney disease taking osteoporosis medicine Prolia (denosumab)

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

FDA warns of rare but serious drug reaction to the antiseizure medicines levetiracetam (Keppra, Keppra XR, Elepsia XR, Spritam) and clobazam (Onfi, Sympazan)

FDA updating warnings to improve safe use of prescription stimulants used to treat ADHD and other conditions

FDA updates prescribing information for all opioid pain medicines to provide additional guidance for safe use

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

FDA warns about possible increased risk of death and serious side effects with cancer drug Copiktra (duvelisib)

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

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

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

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

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

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

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

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

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

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

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