Your FDA gateway for clinically important safety information and reporting serious problems with human medical products.
Tri-Ton by Dynamic Technical Formulations, LLC: Recall - Contains Andarine and Ostarine Drug Ingredients Use or consumption of products containing SARMs and anabolic steroid-like substances may cause acute liver injury, which is known to be a possible harmful effect of using steroid containing products. Posted 05/22/2017 V60 Non-invasive Ventilator by Respironics: Class I Recall - Unexpected Device Shut Down Unexpected stop in ventilation therapy may cause serious adverse health consequences, including death. Posted 05/22/2017 Gadolinium-based Contrast Agents for Magnetic Resonance Imaging (MRI): Drug Safety Communication - No Harmful Effects Identified With Brain Retention Health care professionals should continue to limit GBCA use to circumstances in which additional information provided by the contrast agent is necessary, and assess the necessity of repetitive MRIs with GBCAs. Posted 05/22/2017 LeadCare Testing Systems (with Blood Obtained from a Vein) by Magellan Diagnostics: FDA Safety Communication - Risk of Inaccurate Results Falsely lower test results may lead to improper patient management and treatment for lead exposure or poisoning. Posted 05/17/2017 Wingman35 Crossing Catheters by ReFlow Medical: Recall - Tip Splitting or Separation UPDATED 05/17/2017 Recall classified as class I. Tip splitting has the potential to lead to loss of device function. Tip separation may require medical intervention to retrieve a separated segment or may occlude blood flow to end organs. Posted 05/03/2017
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.