Review recent medication safety notices, affected products, manufacturers, and recall classifications from FDA-related sources.
FDA Requires Safety Labeling Changes for Glucagon-Like Peptide-1 Receptor Agonists (GLP-1 RAs) Due to Potential Increased Risk of Rare But Serious Eye Condition
JXK Enterprises, Inc is voluntarily recalling Boner Bears Chocolate, Lot #BB21125, after being notified that FDA laboratory analysis confirmed the presence of sildenafil, an active ingredient in the FDA-approved prescription drug Viagra, which is not declared on the product label.
FDA Adds Boxed Warning to Labeling for Ferric Carboxymaltose Injection (Injectafer) to Describe Risk of Low Phosphate Levels
FDA Approves Labeling Changes for Over-the-Counter (OTC) Weight Loss Drug alli (Orlistat) to Warn of Risk of Kidney Stones and Kidney Injury
FDA Identifies Cases of Serious Liver Injury in Patients Taking Tavneos (avacopan) for Severe Active Anti-neutrophil Cytoplasmic Autoantibody (ANCA)-associated Vasculitis
FDA adds warning about serious risk of heat-related complications with antinausea patch Transderm Scōp (scopolamine transdermal system)
FDA Alerts Healthcare Professionals About the Risk of Medication Errors with Tranexamic Acid Injection Resulting in Inadvertent Intrathecal (Spinal) Injection
Serious liver injury being observed in patients without cirrhosis taking Ocaliva (obeticholic acid) to treat primary biliary cholangitis
Product type: Drugs. Recall reason: Mislabeled with the incorrect strength on the carton. Company: Endo, Inc.. Brand: Par Pharmaceutical. Product: Clonazepam Orally Disintegrating Tablets, USP (C-IV).
FDA is alerting patients and health care professionals about the voluntary withdrawal of Oxbryta from the market due to safety concerns
FDA warns consumers not to use SnoreStop Nasal Spray by Green Pharmaceuticals due to potential contamination
FDA adds warning about rare occurrence of serious liver injury with use of Veozah (fezolinetant) for hot flashes due to menopause
Product type: Drugs. Recall reason: Mislabeled with the incorrect strength on the carton. Company: Endo USA, Inc. Brand: Par Pharmaceutical. Product: Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.25 mg tablets.
FDA warns consumers of risk of methanol contamination in certain hand sanitizers
FDA adds Boxed Warning for increased risk of severe hypocalcemia in patients with advanced chronic kidney disease taking osteoporosis medicine Prolia (denosumab)
FDA warns consumers not to purchase or use Neptune’s Fix or any tianeptine product due to serious risks
FDA warns consumers not to purchase or use certain eye drops from several major brands due to risk of eye infection
FDA warns consumers not to purchase or use certain methylsulfonylmethane (MSM) eye drops due to contamination
Product type: Drugs. Recall reason: Packaging may contain incorrect product due to labeling mix-up. Company: The Harvard Drug Group, LLC d/b/a Major Pharmaceutical and Rugby Laboratories. Brand: Major Pharmaceuticals. Product: Dronabinol Capsules 2.5mg and Ziprasidone Hydrochloride Capsules 20mg.
FDA warns consumers not to purchase or use EzriCare Artificial Tears due to potential contamination
FDA warns about possible increased risk of death and serious side effects with cancer drug Copiktra (duvelisib)
FDA approval of lymphoma medicine Ukoniq (umbralisib) is withdrawn due to safety concerns
Product type: Animal & Veterinary, Cosmetics, Dietary Supplements, Drugs, Food & Beverages, Medical Devices. Recall reason: Potential Salmonella contamination and presence of rodent activity at the distribution center. Company: Family Dollar, Inc.. Brand: Numerous brand names.…
FDA investigating possible increased risk of death with lymphoma medicine Ukoniq (umbralisib)
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
Due to risk of serious liver injury, FDA restricts use of Ocaliva (obeticholic acid) 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
Initial safety trial results find increased risk of serious heart-related problems and cancer with arthritis and ulcerative colitis medicine Xeljanz, Xeljanz XR (tofacitinib)
FDA removes Boxed Warning about risk of leg and foot amputations for the diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR)
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
Safety clinical trial shows possible increased risk of cancer with weight-loss medicine Belviq, Belviq XR (lorcaserin)
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