October - December 2023 | 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 March 15, 2024)
Acetaminophen-containing products	Metabolic acidosis	FDA is evaluating the need for regulatory action.
Certain adenosine injection (generic product) Certain amiodarone hydrochloride injection (generic product)	Look alike container labels that contribute to wrong drug errors	FDA is evaluating the need for regulatory action.
Alecensa (alectinib) Xalkori (crizotinib)	Acute pancreatitis	FDA is evaluating the need for regulatory action.
Aplenzin (bupropion hydrobromide) Auvelity (dextromethorphan hydrobromide and bupropion hydrochloride) Contrave (naltrexone hydrochloride and bupropion hydrochloride) Forfivo XL (bupropion hydrochloride) Wellbutrin (bupropion hydrochloride) Wellbutrin SR (bupropion hydrochloride) Wellbutrin XL (bupropion hydrochloride extended release)	Meningitis aseptic	FDA is evaluating the need for regulatory action.
Aplenzin (bupropion hydrobromide) Auvelity (dextromethorphan hydrobromide and bupropion hydrochloride) Contrave (naltrexone hydrochloride and bupropion hydrochloride) Forfivo XL (bupropion hydrochloride) Wellbutrin (bupropion hydrochloride) Wellbutrin SR (bupropion hydrochloride) Wellbutrin XL (bupropion hydrochloride extended release)	Brugada syndrome	The “Postmarketing Experience” section of the labeling for Contrave was updated in November 2023 to include Brugada pattern/syndrome. Contrave labeling FDA is evaluating the need for regulatory action for the other drug products.
Beyfortus (nirsevimab-alip)	Hypersensitivity	The “Warnings and Precautions” section of the labeling was updated in February 2024 to include risk of serious hypersensitivity reactions following Beyfortus administration. Beyfortus labeling
Braftovi (encorafenib) Zelboraf (vemurafenib)	Haemophagocytic lymphohistiocytosis	FDA is evaluating the need for regulatory action.
Central Nervous System (CNS) stimulants	Electrocardiogram QT prolonged	FDA is evaluating the need for regulatory action.
Gilotrif (afatinib) Iressa (gefitinib) Tarceva (erlotinib)	Cardiac failure	FDA is evaluating the need for regulatory action.
Gonadotropin releasing hormone (GnRH) agonists Fensolvi (leuprolide acetate) Lupron Depot (leuprolide acetate for depot suspension) Lupron Depot-Ped (leuprolide acetate for depot suspension) Lupaneta Pack (leuprolide acetate for depot suspension, for injection; norethindrone acetate tablets) Supprelin LA (histrelin acetate) Synarel (nafarelin acetate) Triptodur (triptorelin)	Severe cutaneous adverse reactions	FDA is evaluating the need for regulatory action.
Imcivree (setmelanotide)	Hypersensitivity	The “Contraindications”, “Warnings and Precautions”, and “Postmarketing Experience” sections of the labeling were updated in November 2023 to include hypersensitivity reactions. Imcivree labeling
Liptruzet (ezetimibe and atorvastatin) Nexlizet (bempedoic acid and ezetimibe) Roszet (rosuvastatin and ezetimibe) Vytorin (ezetimibe and simvastatin) Zetia (ezetimibe)	Drug-induced liver injury	The “Postmarketing Experience” section of the labeling for Zetia was updated in February 2024 regarding liver transaminases. Zetia Labeling FDA is evaluating the need for regulatory action for the other drug products.
Liptruzet (ezetimibe and atorvastatin) Nexlizet (bempedoic acid and ezetimibe) Roszet (rosuvastatin and ezetimibe) Vytorin (ezetimibe and simvastatin) Zetia (ezetimibe)	Severe cutaneous adverse reaction	FDA decided that no action is necessary at this time based on available information.
Lupkynis (voclosporin)	Hypersensitivity	FDA is evaluating the need for regulatory action.
Systemic (oral/intravenous) metronidazole-containing products	Hearing impairment	FDA is evaluating the need for regulatory action.
Oncaspar (pegaspargase) Rylaze (asparaginase erwinia chrysanthemi (recombinant)- rywn)	Veno-occlusive liver disease	The “Warnings and Precautions” section of the labeling for Oncaspar was updated in March 2024 to include the risk of hepatic veno-occlusive disease. Oncaspar labeling FDA is evaluating the need for regulatory action for Rylaze.
Rybrevant (amivantamab-vmjw)	Anaphylactic reaction	FDA is evaluating the need for regulatory action.
Sphingosine 1-phosphate receptor (S1PR) modulators Mayzent (siponimod) Ponvory (ponesimod) Velsipity (etrasimod) Zeposia (ozanimod)	Drug-induced liver injury	FDA is evaluating the need for regulatory action.
Turalio (pexidartinib)	Posterior reversible encephalopathy syndrome	FDA is evaluating the need for regulatory action.
Veozah (fezolinetant)	Drug-induced liver injury	FDA is evaluating the need for regulatory action.