Your FDA gateway for clinically important safety information and reporting serious problems with human medical products.
Pink Bikini and Shorts on The Beach Dietary Supplements by Lucy's Weight Loss System: Recall - Undeclared Drug Ingredient May contain sibutramine, phenolphthalein, and/or diclofenac. Posted 01/29/2016 Bentonite Me Baby – Bentonite Clay by Alikay Naturals: Consumer Warning - Risk of Lead Poisoning Exposure to lead can cause serious damage to the central nervous system, the kidneys, and the immune system. Posted 01/28/2016 Crema Piel De Seda (Silky Skin Cream) by Viansilk: Consumer Warning - Risk of Mercury Poisoning Exposure to mercury can cause serious health problems, such as kidney and nervous system damage. Posted 01/28/2016 SPOTCHEM II Test Strips by Arkray: Class I Recall - Inaccurate Blood Sugar Readings Because the test strips are reporting falsely low blood glucose, there is a risk that the health care provider would not diagnose hyperglycemia (high blood sugar) in a timely manner and fail to treat elevated blood glucose levels. Posted 01/28/2016 MOVES Ventilator System by Thornhill Research: Class I Recall - Battery Problem The issue may prevent the ventilator from providing patient breathing support and could cause patient injury or death. Posted 01/27/2016 Baxter IV Solutions (Select Lots): Recall - Potential for Leaking Containers and Particulate Matter Solution contamination could lead to a worsened patient condition or death. Posted 01/27/2016 Optisure Dual Coil Defibrillation Leads by St. Jude Medical: Class I Recall - Damage May Prevent Patient Therapy Manufacturing error may have caused damage to the insulation layer of one of the shock coils. This could result in the inability of the defibrillator to deliver electrical therapy to the patient. Posted 01/26/2016
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.