Your FDA gateway for clinically important safety information and reporting serious problems with human medical products.
Dialog+ Hemodialysis Systems by B. Braun Medical: Class I Recall - Defective Conductivity Sensors The presence of air in dialysis fluid may lead to improper blood filtration, causing serious adverse health consequences, including death. Posted 05/04/2016 Beacon Tip Technology Catheters by Cook Medical: Recall - Polymer Degradation of the Catheter Tip Degradation could lead to loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. Posted 05/04/2016 Aripiprazole (Abilify, Abilify Maintena, Aristada): Drug Safety Communication - FDA Warns About New Impulse-control Problems Compulsive or uncontrollable urges to gamble, binge eat, shop, and have sex have been reported with the use of aripiprazole, and may result in harm to the patient and others if not recognized. Posted 05/03/2016 Brintellix (vortioxetine): Drug Safety Communication - Brand Name Change to Trintellix, to Avoid Confusion With Antiplatelet Drug Brilinta (ticagrelor) During transition from the name Brintellix to Trintellix, prescribers can reduce the risk of name confusion by including the generic name of the medication they are ordering, in addition to the brand name and indication for use. Posted 05/02/2016 Making It A Lifestyle, L.L.C. Supplements 3rd Degree, Black Gold X Advanced, and Black Label X: Recall - Undeclared Drug Ingredients Undeclared sibutramine or sildenafil poses a threat to consumers. Posted 05/02/2016
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.