Your FDA gateway for clinically important safety information and reporting serious problems with human medical products.
Bioprosthetic Aortic Valves: FDA Notification - Reduced Leaflet Motion FDA is working to design clinical studies to fully evaluate reduced valve leaflet motion. At this time, FDA believes that bioprosthetic aortic valves remain reasonably safe and effective when used according to their approved indications. Posted 10/05/2015 Drug Products Intended to be Sterile by Chen Shwezin Inc., dba Park Compounding Pharmacy: FDA Statement - Lack of Sterility Assurance Administration of a non-sterile drug product intended to be sterile may result in serious and potentially life-threatening infections or death. Posted 10/03/2015 PROFEMUR Neck Varus/Valgus CoCr 8 Degree, Part number PHAC 1254 by MicroPort Orthopedics: Class I Recall - Unexpected Rate of Fractures After Surgery Acute fracture and emergency revision surgery is a serious adverse health consequence and could lead to neurovascular damage, hematoma, hemorrhage, or death. Posted 10/02/2015
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.