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 October 24, 2025)
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	The carton and container labeling were updated between November 2024 and March 2025 to minimize the risk of wrong drug errors. Example: Nexterone labeling
Cubicin (daptomycin for injection) Cubicin RF (daptomycin for injection) Dapzura RT (daptomycin for injection)	Hyperkalemia	The “Adverse Reactions” section of the labeling was updated in April and May 2025 to include information about hyperkalemia. Example: Cubicin labeling
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	The “Precautions” and “Adverse Reactions” sections of the labeling were updated in April 2025 to include information about the risk of falsely low glycated hemoglobin (HbA1c).
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	The “Dosage and Administration”, “Warnings and Precautions”, “Adverse Reactions”, and “Patient Counseling Information” sections of the labeling were updated in December 2024 for Trikafta to include information about drug-induced liver injury and liver failure. In addition, FDA added a Boxed Warning and approved a new Medication Guide. Trikafta labeling FDA determined that no action was necessary at the time for Kalydeco, Orkambi, and Symdeko based on available information.
Lenvima (lenvatinib) capsules Nexavar (sorafenib) tablets	Tumor lysis syndrome	FDA determined that no action was necessary at the time based on available information.
Syfovre (pegcetacoplan injection)	Hypersensitivity	The “Contraindications” and “Adverse Reactions” sections of the labeling were updated in December 2024 to include information about hypersensitivity. Syfovre labeling
Zolgensma (onasemnogene abeparvovec-xioi) suspension	Hypersensitivity including anaphylaxis	The “Warnings and Precautions,” “Postmarketing Experience,” and “Patient Counseling Information” sections of the labeling for Zolgensma were updated in February 2025 to include Infusion-related Reactions. Zolgensma labeling

Content current as of:

04/13/2026

Source

Medically Reviewed By: Felicia Eddings, Pharm.D.

Clinical :: Oncology :: Nuclear :: Geriatric :: Regulatory :: Technology :: Consulting

"My passion is helping businesses, small and large, perform at their best." - Felicia Udoji-Eddings, Pharm.D.

Dr. Felicia Udoji-Eddings is the Founder and CEO of The Health Pals Company, a vertically integrated Healthcare System. As an experienced Clinical Pharmacy Leader, Pharmacy Consultant, Healthcare Executive, and Licensed Pharmacy Practitioner with deep backgrounds in Information Technology (IT), Scientific Research, and Business Management. Dr. Udoji-Eddings has a strong track record of exceptional performance in different business environments. A skilled Business Strategist, Dr. Udoji-Eddings has tackled complex problems and helped several organizations refocus their strategy in tough economic times. As a highly motivated and proactive individual, Felicia enjoys working with teams, in various capacities, to facilitate positive outcomes.

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