April - June 2024 | New Safety Information or Potential Signals of Serious Risks Identified from the FDA Adverse Event Monitoring System (AEMS)

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 September 20, 2024)
Belsomra (suvorexant) Dayvigo (lemborexant) Quviviq (daridorexant)	Paradoxical drug reaction	FDA is evaluating the need for regulatory action.
Breyna (budesonide and formoterol fumarate) inhalation aerosol	Drug ineffective	FDA is evaluating the need for regulatory action.
Carbaglu (carglumic acid)	Product physical issue that may contribute to clogged feeding tubes	FDA is evaluating the need for regulatory action.
Certain flecainide acetate (generic product) Certain prasugrel hydrochloride (generic product)	Look alike container labels that may contribute to wrong drug errors	The prasugrel container labels were revised in August 2024 to differentiate the products.
Certain tiotropium inhalation powder (generic product)	Device difficult to use	FDA is evaluating the need for regulatory action.
Copaxone (glatiramer acetate)	Anaphylactic reaction	FDA is evaluating the need for regulatory action.
Epinephrine injection (authorized generic for Adrenaclick)	Device use confusion (mismatch between the pen device and Instructions for Use)	FDA is evaluating the need for regulatory action.
Fetroja (cefiderocol)	Chromaturia	FDA is evaluating the need for regulatory action.
Gemtesa (vibegron)	Hypersensitivity	FDA is evaluating the need for regulatory action.
Janus kinase (JAK) inhibitors	Hypoglycemia	FDA is evaluating the need for regulatory action.
Kalydeco (ivacaftor) Orkambi (lumacaftor and ivacaftor) Symdeko (tezacaftor/ivacaftor) Trikafta (elexacaftor, tezacaftor, and ivacaftor)	Increased intracranial pressure disorders	FDA is evaluating the need for regulatory action.
Mekinist (trametinib)	Acute febrile neutrophilic dermatosis	FDA is evaluating the need for regulatory action.
Potassium Phosphates Injection Sodium Chloride 0.9% Injection	Look alike containers that may contribute to wrong drug errors	FDA is evaluating the need for regulatory action.
Pyzchiva (ustekinumab-ttwe) Stelara (ustekinumab) Selarsdi (ustekinumab-aekn) Wezlana (ustekinumab-auub)	Hepatobiliary disorders	FDA is evaluating the need for regulatory action.
Singulair (montelukast sodium)	Psychiatric disorders	FDA is evaluating the need for regulatory action.
Tafinlar (dabrafenib) Zelboraf (vemurafenib)	Acute febrile neutrophilic dermatosis	FDA is evaluating the need for regulatory action.
Tazverik (tazemetostat)	Blood glucose abnormal	FDA is evaluating the need for regulatory action.
Thrombin-JMI (thrombin, topical [bovine])	Inadvertent intravenous (IV) administration causing thrombosis	FDA is evaluating the need for regulatory action.