Your FDA gateway for clinically important safety information and reporting serious problems with human medical products.
Gilenya (fingolimod): Drug Safety Communication - FDA Warns About Cases of Rare Brain Infection Cases of PML in two patients with no prior exposure to immunosuppressant drugs. Posted 08/04/2015 Duodenoscope Reprocessing: FDA Safety Communication - Supplemental Measures to Enhance Reprocessing Hospitals and health care facilities can, in addition to meticulously following manufacturer reprocessing instructions, take additional steps to further reduce the risk of infection. Posted 08/04/2015 Hydrochlorothiazide Tablets by Unichem Pharmaceuticals (USA), Inc: Recall - Potential Presence of Foreign Tablets Contamination Missing a dose of Hydrochlorothiazide could result in uncontrolled blood pressure or swelling caused by excess fluid (edema). Posted 07/31/2015 Symbiq Infusion System by Hospira: FDA Safety Communication - Cybersecurity Vulnerabilities The device could be accessed remotely through a hospital’s network. This could allow an unauthorized user to control the device and change the dosage the pump delivers, which could lead to over- or under-infusion of critical patient therapies. Posted...
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.