July - September 2024 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)
The drug product(s) included in any of the potential signals of serious risks/new safety information listed below may also include the generic version of the drug product(s), if there are generic versions approved for use by the FDA at the time of this publication.
| Product Name: Trade (Active Ingredient) or Product Class | Potential Signal of a Serious Risk / New Safety Information | Additional Information (as of December 9, 2024) |
|---|---|---|
Alecensa (alectinib) capsules Alunbrig (brigatinib) tablets Xalkori (crizotinib) capsules Xalkori (crizotinib) oral pellets | Severe cutaneous adverse reaction | FDA is evaluating the need for regulatory action. |
Cardene IV (nicardipine hydrochloride) in sodium chloride injection Certain vasopressin in sodium chloride injection Myxredlin (human insulin) in sodium chloride injection Nexterone (amiodarone hydrochloride) Premixed Injection Zosyn (piperacillin sodium and tazobactam sodium) injection | Look alike container labels or carton labeling that may contribute to wrong drug errors | FDA is evaluating the need for regulatory action. |
Cubicin (daptomycin for injection) Cubicin RF (daptomycin for injection) Dapzura RT (daptomycin for injection) | Hyperkalemia | FDA is evaluating the need for regulatory action. |
| Entyvio (vedolizumab) injection | Infections and infestations | FDA is evaluating the need for regulatory action. |
| Generic products available in oral dosage form containing dapsone | Glycosylated hemoglobin decreased | FDA is evaluating the need for regulatory action. |
Kalydeco (ivacaftor) tablets
Kalydeco (ivacaftor) oral granules
Orkambi (lumacaftor and ivacaftor) tablets
Orkambi (lumacaftor and ivacaftor) oral granules
Symdeko (tezacaftor/ivacaftor) tablets; (ivacaftor) tablets
Trikafta (elexacaftor, tezacaftor, and ivacaftor tablets; ivacaftor tablets), co-packaged Trikafta (elexacaftor, tezacaftor, and ivacaftor oral granules; ivacaftor oral granules), co-packaged | Drug-induced liver injury | FDA is evaluating the need for regulatory action. |
Lenvima (lenvatinib) capsules Nexavar (sorafenib) tablets | Tumor lysis syndrome | FDA is evaluating the need for regulatory action. |
| Syfovre (pegcetacoplan injection) | Hypersensitivity | FDA is evaluating the need for regulatory action. |
| Zolgensma (onasemnogene abeparvovec-xioi) suspension | Hypersensitivity including anaphylaxis | FDA is evaluating the need for regulatory action. |