Your FDA gateway for clinically important safety information and reporting serious problems with human medical products.
January 2016 Drug Safety Labeling Changes includes 26 products with revisions to Prescribing Information. Posted 02/12/2015 Central Venous Catheters and Pressure Monitoring Sets and Trays by Cook Medical: Recall - Catheter Tip Fracture and/or Separation Risk of stroke, kidney injury, or damage to the intestines or limbs. Posted 02/11/2016 Syrspend SF and Syrspend SF Grape Suspending Agents by Fagron: FDA Alert - Microbial Contamination with Yeast If an immunocompromised patient or a child with an immature immune system ingests the contaminated product, there is a potential the patient will get an infection for which systemic antimicrobial therapy would be necessary. Posted 02/10/2016 Oxylog 2000 Plus, 3000, and 3000 Plus Emergency Transport Ventilators by Dräger Medical: Class I Recall - System Error May Lead to a Halt in Ventilation Therapy If the device operator does not intervene, the patient may not receive enough oxygen and could suffer serious adverse health consequences, including injury or death. Posted 02/10/2016 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
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.