Acetaminophen Stevens-Johnson Syndrome FDA is evaluating the need for regulatory action. Ajovy (fremanezumab-vfrm) Vyepti (eptinezumab-jjmr) Anaphylactic reaction The “Contraindications”, “Warnings and Precautions”, “Adverse Reactions”, and “Patient […]

Actemra (tocilizumab) Hepatitis B reactivation FDA determined that no action is necessary at this time based on available information. Alcohol containing hand sanitizers Blood methanol induced […]

Aimovig (erenumab-aooe) Wrong strength FDA decided that no action is necessary at this time based on available information. Aimovig (erenumab-aooe) Product preparation error The carton labeling, […]

Bridion (sugammadex) injection Arteriospasm coronary (coronary vasospasm) The “Adverse Reactions” section of the labeling was updated in January 2021 to include coronary spasm. Bridion labeling Bydureon […]

CisplatinGeneric products containing cisplatin Aortic thrombosis FDA has determined that the last approved labeling is adequate, and that no further regulatory action is needed at this […]