Drug Safety Communications

Español 药物安全通讯 Drug Safety Podcasts FDA Drug Safety Communications are intended to provide important information to patients and health care professionals about new safety issues with the medicines they are taking or prescribing so they can make more informed decisions about treatment. Widespread or long-term use of drugs by patients may uncover side effects not discovered during the clinical trials a drug company did to get FDA approval of the medicine. As a result, FDA physicians and scientists continue to monitor the safety of drugs after they are approved. When we learn information about a potential new safety issue, we review the data from available clinical trials or other studies, case reports, and medical literature. Based on what we find, we may require changes to the prescribing information or the patient Medication Guide. We may also release a Drug Safety Communication to alert patients and health care professionals about the issue. Read more. You can get new safety information on medicines you’re prescribing or taking by signing up for email alerts about Drug Safety Communications on types of drugs or medical specialties of specific interest to you. Drug Safety CommunicationsDate Title 3-31-2026 FDA Identifies Cases of Serious Liver Injury in Patients Taking Tavneos (avacopan) for Severe Active Anti-neutrophil Cytoplasmic Autoantibody (ANCA)-associated Vasculitis 3-20-2026 FDA Is Requiring Warning about Vitamin B6 Deficiency and Associated Seizures for Drug Products Containing Carbidopa/Levodopa 1-13-2026 FDA Requests Removal of Suicidal Behavior and Ideation Warning from Glucagon-Like Peptide-1 Receptor Agonist (GLP-1 RA) Medications 8-28-2025 FDA to recommend additional, earlier MRI monitoring for patients with Alzheimer’s disease taking Leqembi (lecanemab) 8-27-2025 FDA removes risk evaluation and mitigation strategy (REMS) program for the antipsychotic drug Clozapine 7-31-2025 FDA is requiring opioid pain medicine manufacturers to update prescribing information regarding long-term use 6-30-2025 FDA requires expanded labeling about weight loss risk in patients younger than 6 years taking extended-release stimulants for ADHD 6-18-2025 FDA adds warning about serious risk of heat-related complications with antinausea patch Transderm Scōp (scopolamine transdermal system) 5-16-2025 FDA requires warning about rare but severe itching after stopping long-term use of oral allergy medicines cetirizine or levocetirizine (Zyrtec, Xyzal, and other trade names) 1-22-2025 FDA adds Boxed Warning about a rare but serious allergic reaction called anaphylaxis with the multiple sclerosis medicine glatiramer acetate (Copaxone, Glatopa) 12-12-2024 Serious liver injury being observed in patients without cirrhosis taking Ocaliva (obeticholic acid) to treat primary biliary cholangitis 9-12-2024 FDA adds warning about rare occurrence of serious liver injury with use of Veozah (fezolinetant) for hot flashes due to menopause 1-19-2024 FDA adds Boxed Warning for increased risk of severe hypocalcemia in patients with advanced chronic kidney disease taking osteoporosis medicine Prolia (denosumab) 1-11-2024 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 11-28-2023 FDA warns of rare but serious drug reaction to the antiseizure medicines levetiracetam (Keppra, Keppra XR, Elepsia XR, Spritam) and clobazam (Onfi, Sympazan) 5-11-2023 FDA updating warnings to improve safe use of prescription stimulants used to treat ADHD and other conditions 4-13-2023 FDA updates prescribing information for all opioid pain medicines to provide additional guidance for safe use 6-30-2022 FDA warns about possible increased risk of death and serious side effects with cancer drug Copiktra (duvelisib) 6-1-2022 FDA approval of lymphoma medicine Ukoniq (umbralisib) is withdrawn due to safety concerns 3-30-2022 FDA recommends thyroid monitoring in babies and young children who receive injections of iodine-containing contrast media for medical imaging 2-3-2022 FDA investigating possible increased risk of death with lymphoma medicine Ukoniq (umbralisib) 1-12-2022 FDA warns about dental problems with buprenorphine medicines dissolved in the mouth to treat opioid use disorder and pain 11-2-2021 FDA warns that getting alcohol-based hand sanitizer in the eyes can cause serious injury 9-1-21 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 7-20-2021 FDA requests removal of strongest warning against using cholesterol-lowering statins during pregnancy; still advises most pregnant patients should stop taking statins 6-16-2021 FDA warns that vapors from alcohol-based hand sanitizers can have side effects 5-26-2021 Due to risk of serious liver injury, FDA restricts use of Ocaliva (obeticholic acid) in primary biliary cholangitis (PBC) patients with advanced cirrhosis 3-31-2021 Studies show increased risk of heart rhythm problems with seizure and mental health medicine lamotrigine (Lamictal) in patients with heart disease 3-25-2021 FDA warns that abuse and misuse of the nasal decongestant propylhexedrine causes serious harm 2-4-2021 Initial safety trial results find increased risk of serious heart-related problems and cancer with arthritis and ulcerative colitis medicine Xeljanz, Xeljanz XR (tofacitinib) 10-15-2020 FDA recommends avoiding use of NSAIDs in pregnancy at 20 weeks or later because they can result in low amniotic fluid 9-24-2020 FDA warns about serious problems with high doses of the allergy medicine diphenhydramine (Benadryl) 9-23-2020 FDA requiring Boxed Warning updated to improve safe use of benzodiazepine drug class 8-26-2020 FDA removes Boxed Warning about risk of leg and foot amputations for the diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR) 7-23-2020 FDA recommends health care professionals discuss naloxone with all patients when prescribing opioid pain relievers or medicines to treat opioid use disorder 4-24-2020 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 3-4-2020 FDA requires Boxed Warning about serious mental health side effects for asthma and allergy drug montelukast (Singulair); advises restricting use for allergic rhinitis 2-13-2020 FDA requests the withdrawal of the weight-loss drug Belviq, Belviq XR (lorcaserin) from the market 1-28-2020 FDA strengthens warning that untreated constipation caused by schizophrenia medicine clozapine (Clozaril) can lead to serious bowel problems 1-14-2020 Safety clinical trial shows possible increased risk of cancer with weight-loss medicine Belviq, Belviq XR (lorcaserin) Resources Content current as of: 04/03/2026 Regulated Product(s) Topic(s)