Your FDA gateway for clinically important safety information and reporting serious problems with human medical products.
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 Sensorcaine-MPF (bupivacaine HCl) by Fresenius Kabi: Recall - Presence of Particulate Matter Administration of a solution containing glass particulate matter may result in inflammation and injury, or cause blockage of vasculature around the eye or emboli in the vasculature of eye nerves. Posted 04/26/2016 Fluconazole (Diflucan): Drug Safety Communication - FDA Evaluating Study Examining Use of Oral Fluconazole (Diflucan) in Pregnancy Danish study shows possible increased risk of miscarriage. FDA advises cautious prescribing of oral fluconazole in pregnancy, until more is understood about this study. Posted 04/26/2016 Covidien Oridion Labeled Capnostream 20 and Capnostream 20p Patient Monitor Battery Packs by Medtronic: Recall - Risk of Thermal Damage Thermal damage may cause fire, resulting in smoke inhalation and minor burns. Posted 04/20/2016 Sterile Drug Products from Pharmakon Pharmaceuticals: Recall - 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 04/16/2016
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.