April - June 2021 | 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 10, 2021)
Adcetris (brentuximab vedotin)	Guillain-Barre syndrome	FDA is evaluating the need for regulatory action.
Arzerra (ofatumumab) Gazyva (obinutuzumab) Riabni (rituximab-arrx) Rituxan (rituximab) Rituxan Hycela (rituximab hyaluronidase human) Ruxience (rituximab-pvvr) Truxima (rituximab-abbs)	Colitis	FDA is evaluating the need for regulatory action.
Balversa (erdafitinib)	Calciphylaxis	FDA is evaluating the need for regulatory action.
Bavencio (avelumab) Keytruda (pembrolizumab) Opdivo (nivolumab) Yervoy (ipilimumab)	Necrotizing fasciitis	FDA is evaluating the need for regulatory action.
Beta-blockers Betapace (sotalol hydrochloride) Betapace AF (sotalol hydrochloride) Brevibloc (esmolol hydrochloride) Bystolic (nebivolol) Byvalson (nebivolol and valsartan) Coreg (carvedilol) Coreg CR (carvedilol) Corgard (nadolol) Corzide (nadolol and bendroflumethiazide) Dutoprol (metoprolol succinate and hydrochlorothiazide) Kapspargo Sprinkle (metoprolol succinate) Levatol (penbutolol sulfate) Lopressor HCT  (metoprolol tartrate and hydrochlorothiazide) Sectral (acebutolol hydrochloride) Sotylize (sotalol hydrochloride) Tenoretic (atenolol and chlorthalidone) Toprol XL (metoprolol succinate) Trandate (labetalol hydrochloride) Zebeta (bisoprolol fumarate) Ziac (bisoprolol fumarate and hydrochlorothiazide) Generic products containing beta-blockers	Hypoglycaemia in pediatric patients	FDA is evaluating the need for regulatory action.
Bosulif (bosutinib monohydrate) Gleevec (imatinib mesylate) Iclusig (ponatinib) Sprycel (dasatinib) Tasigna (nilotinib)	Osteonecrosis	FDA is evaluating the need for regulatory action.
Cablivi (caplacizumab-yhdp)	Haemorrhage	FDA is evaluating the need for regulatory action.
Cyramza (ramucirumab)	Cardiac failure	FDA is evaluating the need for regulatory action.
Docetaxel Taxotere (docetaxel)	Rhabdomyolysis	FDA is evaluating the need for regulatory action.
Doxil (doxorubicin hydrochloride)	Acute interstitial pneumonitis	FDA is evaluating the need for regulatory action.
Gleevec (imatinib mesylate) Tasigna (nilotinib)	Myasthenia gravis	FDA is evaluating the need for regulatory action.
Ibrance (palbociclib) Kisqali (ribociclib) Kisqali Femara Co-Pack (ribociclib; letrozole) Verzenio (abemaciclib)	Radiation recall phenomenon	FDA is evaluating the need for regulatory action.
Lokelma (sodium zirconium cyclosilicate)	Gastrointestinal disorders	FDA is evaluating the need for regulatory action.
Padcev (enfortumab vedotin-ejfv)	Pancreatitis	FDA is evaluating the need for regulatory action.
Padcev (enfortumab vedotin-ejfv)	Pneumonitis	FDA is evaluating the need for regulatory action.
Poteligeo (mogamulizumab-kpkc)	Cytomegalovirus viraemia	FDA is evaluating the need for regulatory action.
Procysbi (cysteamine bitartrate) Generic products containing cysteamine bitartrate	Fibrosing colonopathy	FDA is evaluating the need for regulatory action.
Sarclisa (isatuximab-irfc)	Herpes zoster	FDA is evaluating the need for regulatory action.
Sprycel (dasatinib)	Drug-induced liver injury	FDA is evaluating the need for regulatory action.
Veklury (remdesivir)	Bradycardia	FDA is evaluating the need for regulatory action.
Zepzelca (lurbinectedin)	Extravasation	FDA is evaluating the need for regulatory action.
Zepzelca (lurbinectedin)	Tumor lysis syndrome	FDA is evaluating the need for regulatory action.
Zepzelca (lurbinectedin)	Rhabdomyolysis	FDA is evaluating the need for regulatory action.