Your FDA gateway for clinically important safety information and reporting serious problems with human medical products.
Canagliflozin (Invokana, Invokamet) and Dapagliflozin (Farxiga, Xigduo XR): Drug Safety Communication - Strengthened Kidney Warnings Revised warnings in the drug labels to include information about acute kidney injury and added recommendations to minimize this risk. Posted 06/14/2016 Zecuity (sumatriptan) Migraine Patch: Drug Safety Communication - FDA Evaluating Risk of Burns and Scars UPDATED 06/13/2016: Health care professionals should discontinue prescribing Zecuity, and patients should stop using any remaining patches and contact their prescribers for an alternative migraine medicine. Originally posted 06/02/2016 May 2016 Drug Safety Labeling Changes includes 86 products with revisions to Prescribing Information. Posted 06/10/2016 Nature Made (Various Products) by Pharmavite LLC: Recall - Possible Health Risk Salmonella can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Posted 06/08/2016
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.