April - June 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 September 28, 2020)
Aimovig (erenumab-aooe)	Wrong strength	FDA decided that no action is necessary at this time based on available information.
Aimovig (erenumab-aooe)	Product preparation error	FDA is evaluating the need for regulatory action.
Ajovy (fremanezumab) Aimovig (erenumab-aooe) Emgality (galcanezumab) Vyepti (eptinezumab)	Stevens-Johnson syndrome (SJS)	FDA is evaluating the need for regulatory action.
Aubagio (teriflunomide) Generic products containing teriflunomide	Drug reaction with eosinophilia and systemic symptoms	FDA is evaluating the need for regulatory action.
Darzalex (daratumumab) Darzalex Faspro (daratumumab and hyaluronidase-fihj)	Listeriosis	FDA is evaluating the need for regulatory action.
Erleada (apalutamide)	Toxic epidermal necrolysis	FDA is evaluating the need for regulatory action.
Fibric acid derivatives Antara (fenofibrate) Fenoglide (fenofibrate) Fibrocor (fenofibric acid) Lipofen (fenofibrate) Triglide (fenofibrate) Tricor (fenofibrate) Trilipix (choline fenofibrate) Generic products containing fibric acid derivatives	Drug-induced liver injury	FDA is evaluating the need for regulatory action.
Glucagon-like peptide 1 (GLP-1) Receptor Agonists Adlyxin (lixisenatide) Bydureon (exenatide) Bydureon BCise (exenatide) Byetta (exenatide) Ozempic (semaglutide) Rybelsus (semaglutide) Saxenda (liraglutide) Soliqua (insulin glargine and lixisenatide) Tanzeum (albiglutide) Trulicity (dulaglutide) Victoza (liraglutide) Xultophy (insulin degludec/liraglutide)	Hypoglycaemia	FDA is evaluating the need for regulatory action.
Ibrance (palbociclib)	Stevens-Johnson syndrome	FDA is evaluating the need for regulatory action.
Kadcyla (ado-trastuzumab emtansine)	Skin vascular abnormalities (e.g., telangiectasia, spider nevus, spider angioma)	FDA decided that no action is necessary at this time based on available information.
Kisqali (ribociclib) Kisqali Femara co-pack (ribociclib, letrozole)	Stevens-Johnson syndrome	FDA is evaluating the need for regulatory action.
Lipitor (atorvastatin)	Drug interaction between atorvastatin and hepatitis C virus (HCV) NS5A/NS5B inhibitors	FDA is evaluating the need for regulatory action.
Mammalian target of rapamycin (mTOR) inhibitors Afinitor (everolimus) Afinitor Disperz (everolimus) Torisel (temsirolimus) Associated generic products containing everolimus or temsirolimus	Radiation recall phenomenon	FDA is evaluating the need for regulatory action.
Nuzyra (omadacycline tosylate)	Wrong dose	FDA decided that no action is necessary at this time based on available information.
Ocaliva (obeticholic acid)	Liver disorder	FDA is evaluating the need for regulatory action.
Ocrevus (ocrelizumab)	Hepatitis B reactivation	FDA is evaluating the need for regulatory action.
Plaquenil (hydroxychloroquine sulfate) Chloroquine phosphate Generic products containing hydroxychloroquine and chloroquine	Cardiotoxicity	FDA is evaluating the need for regulatory action.
Proton Pump Inhibitors Aciphex (rabeprazole sodium) Dexilan (dexlansoprazole) Esomeprazone strontium Nexium (esomeprazole magnesium) Prevacid (lansoprazole) Prilosec (omeprazole) Protonix (pantoprazole sodium) Vimovo (esomeprazole magnesium and naproxen) Yosprala (aspirin and omeprazole) Zegerid (omeprazole and sodium bicarbonate) Generic products containing proton pump inhibitors	Hypocalcemia and parathyroid hormone disorders	FDA is evaluating the need for regulatory action.
Sublocade (buprenorphine)	Injection site necrosis	FDA is evaluating the need for regulatory action.
Tysabri (natalizumab)	Neonatal thrombocytopenia	FDA is evaluating the need for regulatory action.
Vinca alkaloids Vincristine sulfate Vinblastine sulfate Vinorelbine tartrate	Incorrect route of product administration	FDA is evaluating the need for regulatory action.
Xiidra (lifitegrast)	Hypersensitivity	FDA decided that no action is necessary at this time based on available information.
Xtandi (enzalutamide)	Severe cutaneous adverse reactions	FDA is evaluating the need for regulatory action.
Zolgensma (onasemnogene abeparvovec-xioi)	Thrombotic microangiopathy	FDA is evaluating the need for regulatory action.