MedWatch: The FDA Safety Information and Adverse Event Reporting Program
Your FDA gateway for clinically important safety information and reporting serious problems with human medical products.
Unintentional Injection of Soft Tissue Filler into Blood Vessels in the Face: FDA Safety Communication - Risk of Serious Patient Injury Risk of embolization, which can cause vision impairment, blindness, stroke and damage and/or death of the skin and underlying facial structures. Posted 05/28/2015 Avea Ventilator by CareFusion: Recall - Potential Malfunction of Pressure Transducer Ventilator may activate false Extended High Ppeak or Circuit Occlusion audio and visual alarms, open the safety valve and stop ventilating. Posted 05/27/2015 Zerbaxa (ceftolozane and tazobactam): Drug Safety Communication - FDA Cautions About Dose Confusion and Medication Errors Can lead to administration of more drug than was prescribed. Posted 05/20/2015
FDA Approved Safety Information
DailyMed (National Library of Medicine)
Current Drug Prescribing Information. (NOTE: Drugs marked "unapproved" on this site have not been reviewed by FDA for safety and efficacy, and their labeling has not been approved.)
Paper handouts that come with many prescription medicines. Medication Guides address issues specific to particular drugs and drug classes. They contain FDA-approved information that can help patients avoid serious adverse events.
Potential Signals of Serious Risks/New Safety Information Identified from the FDA Adverse Event Reporting System (FAERS) Postmarket Drug and Biologic Safety Evaluations
Evaluations performed 18 months after drug approval, or after its use by 10,000 individuals.