July - September 2020 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

Product Name: Trade (Active Ingredient) or Product Class	Potential Signal of a Serious Risk / New Safety Information	Additional Information (as of January 14, 2021)
Actemra (tocilizumab)	Hepatitis B reactivation	FDA is evaluating the need for regulatory action.
Alcohol containing hand sanitizers	Blood methanol induced blindness and death	Regulatory actions taken. For additional details, refer to: www.fda.gov/handsanitizerlist
Aubagio (teriflunomide) Generic products containing teriflunomide	Nail disorder	FDA is evaluating the need for regulatory action.
Aubagio (teriflunomide) Generic products containing teriflunomide	Tooth disorder	FDA is evaluating the need for regulatory action.
Benadryl (diphenhydramine) Generic products containing diphenhydramine hydrochloride	Drug abuse and dependence	FDA decided that no action is necessary at this time based on available information. FDA Drug Safety Communication (9/24/2020)
Bosulif (bosutinib monohydrate) Gleevec (imatinib mesylate) Generic drugs containing imatinib mesylate	Facial paralysis	FDA decided that no action is necessary at this time based on available information.
Cyklokapron (tranexamic acid) injection Generic products containing tranexamic acid	Wrong route of administration error (inadvertent intrathecal administration instead of recommended intravenous administration)	The prescribing information was updated to include the risk of medication errors due to incorrect route of administration. The carton and container labeling was also revised to highlight the recommended intravenous route of administration. FDA Safety Communication to Healthcare Providers (12/3/2020)
Darzalex (daratumumab)	Ocular toxicity	FDA is evaluating the need for regulatory action.
Entyvio (vedolizumab)	Pancreatitis	FDA is evaluating the need for regulatory action.
Finasteride Plus 1.25mg capsules (compounded drug) Minoxidil (compounded drug)	Cardiac effects related to undeclared or higher than labeled dose of minoxidil that include tachycardia, low blood pressure, and salt and water retention causing swelling	Voluntary recall
Metronidazole Metronidazole benzoate Metronidazole hydrochloride Metronidazole hydrocholride C-14 Metronidazole phosphate Generic products containing metronidazole	Torsade de pointes/ QT prolongation	FDA is evaluating the need for regulatory action.
Otezla (apremilast) Generic products containing apremilast	Hypersensitivity	FDA is evaluating the need for regulatory action.
Polidocanol (compounded drug)	Product Compounding Quality	FDA is evaluating the need for regulatory action.
Proton Pump Inhibitors AcipHex (raberprazole sodium) AcipHex Sprinkle (raberprazole sodium) Dexilant (dexlansoprazole) Nexium (esomeprazole) Nexium 24 HR (esomeprazole magnesium) Nexium IV (esomeprazole sodium) Omeclamox-Pak (omeprazole, clarithromycin, amoxicillin) Prevacid (lansoprazole) Prevacid 24 HR (lansoprazole) Prevacid SoluTab (lansoprazole) Prilosec (omeprazole) Prilosec OTC (omeprazole magnesium) Protonix (pantoprazole) Protonix IV (pantoprazole sodium) Talicia (omeprazole magnesium, amoxicillin, ribafutin) Vimovo (esomeprazole magnesium and naproxen) Yosprala (aspirin and omeprazole) Zegerid (omeprazole and sodium bicarbonate) Zegerid OTC (omeprazole and sodium bicarbonate) Generic products containing proton pump inhibitors	Rhabdomyolysis	FDA is evaluating the need for regulatory action.
Rinvoq (upadacitinib)	Hypersensitivity	FDA is evaluating the need for regulatory action.
Teflaro (ceftaroline fosamil)	Neurotoxicity	The “Warnings and Precautions,” “Adverse Reactions” and “Patient Counseling Information” sections of the labeling for Teflaro were updated November 2020 to include neurological adverse reactions. Teflaro labeling
Testosterone Pellets (compounded drug)	Breast Cancer	FDA decided that no action is necessary at this time based on available information.
Zinacef (cefuroxime) Ceftin (cefuroxime axetil) Generic products containing cefuroxime	Kounis syndrome (Acute myocardial ischemia with or without myocardial infarction that may occur as part of an allergic reaction)	FDA is evaluating the need for regulatory action.
Zyvox (linezolid) Generic products containing linezolid	Inappropriate antidiuretic hormone secretion	FDA is evaluating the need for regulatory action.