Your FDA gateway for clinically important safety information and reporting serious problems with human medical products.
AVEA Ventilator by CareFusion: Class I Recall - Electrical Issue May Cause Unexpected Shutdown Ventilator shutdown may cause serious adverse health consequences, including death. Posted 07/28/2016 Fluoroquinolone Antibacterial Drugs for Systemic Use: Drug Safety Communication - Warnings Updated Due to Disabling Side Effects Use associated with disabling and potentially permanent side effects of the tendons, muscles, joints, nerves, and central nervous system that can occur together in the same patient. Posted 07/26/2016 HCG and Sermorelin by Talon Compounding Pharmacy: Recall - Lack of Sterility Assurance Administration of a drug product intended to be sterile that is compromised can result in health hazards including risk of serious infection or other complications. Posted 07/22/2016 Angiodynamics Soft Vu Omni Flush Angiographic Catheter by Stryker Sustainability Solutions (formerly Ascent Healthcare Solutions): Class I Recall - Tip Separation Risk of surgical intervention to retrieve a separated segment, or other serious adverse health consequences such as internal organ injury, stroke, kidney failure, intestinal failure, and death. Posted 07/22/2016
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.