Ajovy (fremanezumab-vfrm) Emgality (galcanezumab-gnlm) Nurtec ODT (rimegepant) Ubrelvy (ubrogepant) Vyepti (eptinezumab-jjmr) Hypertension The “Warnings and Precautions”, “Adverse Reactions”, “Patient Counseling Information”, and “Patient Information” sections of […]

Adcetris (brentuximab vedotin) Guillain-Barre syndrome FDA determined that no action is necessary at the time based on available information. Arzerra (ofatumumab)Gazyva (obinutuzumab)Riabni (rituximab-arrx)Rituxan (rituximab)Rituxan Hycela (rituximab […]

Addyi (flibanserin) Drug hypersensitivity The “Contraindications”, “Warnings and Precautions”, “Adverse Reactions”, and “Medication Guide” sections of the labeling were updated in September 2021 to include hypersensitivity […]

Summary Company Announcement Date: August 28, 2025 FDA Publish Date: August 29, 2025 Product Type: Drugs Reason for Announcement: Recall Reason Description Undeclared prescription drug-Tadalafil Company […]

Summary Company Announcement Date: August 27, 2025 FDA Publish Date: August 28, 2025 Product Type: Drugs Reason for Announcement: Recall Reason Description Device & Drug Safety […]

During routine pharmacovigilance, FDA identified six fatal cases of amyloid related imaging abnormalities with edema (ARIA-E) early in treatment. These fatalities prompted an in-depth analysis of […]

Considering an online pharmacy? Have you or someone you know thought about buying prescription medicine online? FDA’s BeSafeRx campaign helps consumers learn about how to safely […]

Online Pharmacy Risks and Safety Precautions FDA provides additional information and resources for consumers who are thinking of buying prescription medicine online. State pharmacy boards The […]

How does a fat-dissolving injection (injection lipolysis) work? Injection lipolysis (“lipo” = fat, “lysis” = breakdown) is a nonsurgical procedure that involves administering a series of […]