Your FDA gateway for clinically important safety information and reporting serious problems with human medical products.
TAH-t Companion 2 Driver System (C2) and Freedom Driver System by SynCardia Systems: Letter to Health Care Providers - Mortality and Neurological Adverse Event Results The most recent post-approval study results assessing post-market performance is available. Posted 10/26/2016 Testosterone and Other Anabolic Androgenic Steroids (AAS): FDA Statement - Risks Associated With Abuse and Dependence New Warning and updated Abuse and Dependence sections of labeling, including new safety information from published literature and case reports. Posted 10/25/2016 HeartWare Ventricular Assist Device (HVAD) Pumps by HeartWare Inc.: Class I Recall - Contamination Causing Electrical Issues Contamination of the driveline may result in fluid or other material entering the pump and causing electrical issues or pump stops that may lead to serious adverse health consequences, including death. Posted 10/24/2016 Willy Rusch Tracheostomy Tube Set by TeleFlex Medical: Class I Recall - Possible Disconnection During Patient Use Connector detachment during use can deprive patient of adequate ventilation and require immediate medical intervention. Posted 10/20/2016
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.