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. |
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Content current as of:
10/03/2024
