Your FDA gateway for clinically important safety information and reporting serious problems with human medical products.
HCG and Sermorelin by Talon Compounding Pharmacy: Recall - Lack of Sterility Assurance Administration of a drug product intended to be sterile that is compromised can result in health hazards including risk of serious infection or other complications. Posted 07/22/2016 Angiodynamics Soft Vu Omni Flush Angiographic Catheter by Stryker Sustainability Solutions (formerly Ascent Healthcare Solutions): Class I Recall - Tip Separation Risk of surgical intervention to retrieve a separated segment, or other serious adverse health consequences such as internal organ injury, stroke, kidney failure, intestinal failure, and death. Posted 07/22/2016 WEN by Chaz Dean Cleansing Conditioners: FDA Statement - Investigation of Adverse Event Reports Reports of hair loss, hair breakage, balding, itching, and rash. Posted 07/19/2016 Oral Liquid Docusate Sodium by PharmaTech : Recall - Contaminated with B. Cepacia The agency confirmed the product has been contaminated with Burkholderia Cepacia, a bacteria linked to an outbreak in five states. Posted 07/16/2016 INRatio and INRatio2 PT/INR Monitor System by Alere: Recall - Potentially Inaccurate INR Results Alere is working with the FDA to determine the most appropriate timing for product discontinuation and will provide guidance on transitioning patients to an alternate solution. Posted 07/12/2016 June 2016 Safety Labeling Changes includes 42 products with revisions to Prescribing Information. Posted 07/07/2016 Dream Body 450mg, Dream Body Extreme Gold 800mg, Dream Body Advanced 400mg: Recall - Undeclared Drug Ingredient Sibutramine may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. Posted 07/05/2016
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.