Safety
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MedWatch: The FDA Safety Information and Adverse Event Reporting Program
Your FDA gateway for clinically important safety information and reporting serious problems with human medical products. |
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What's New
FDA Statement on Fungal Meningitis Outbreak: Additional Patient Notification Advised [UPDATED 10/18/2012] Presence of a fungus known as Exserohilum rostratum confirmed in unopened medication vials. Patient Notification Letter now available. Originally posted 10/15/2012 September 2012 Safety Labeling Changes includes 60 products with revisions to Prescribing Information. Posted 10/17/2012 Accutron, Inc. Ultra PC% Cabinet Mount Flowmeters for Nitrous Oxide-Oxygen Sedation Systems: Class I Recall - Flowmeter May Continue To Release Nitrous Oxide Gas When The Oxygen Is Turned Off When not mixed with oxygen, inhaling nitrous oxide can lead to temporary and permanent brain damage and death. Posted 10/16/2012 New England Compounding Center (NECC) Potentially Contaminated Medication: Fungal Meningitis Outbreak [UPDATED 10/06/2012] Recall from NECC with full list of products is now linked. CDC and FDA recommends all health care professionals cease use and remove from their pharmaceutical inventory any product produced by the NECC. Originally Posted 10/05/2012 Hospira Lactated Ringer's And 5% Dextrose Injection, 1000 Ml, Flexible Containers: Recall - Mold Contamination Voluntary Nationwide Recall Of One Lot. Injections of mold could potentially lead to septicemia, which in a worst-case scenario may have the potential to progress to septic shock, which may be life threatening. Posted 10/06/2012 Stryker Instruments Neptune 1 Silver and Neptune 2 Ultra Waste Management System (Neptune 1 Silver and Neptune 2 Ultra): Safety Communication - Reports of Serious Tissue Damage Incorrect use can cause hemorrhaging and soft tissue, muscle, and vital organ damage, which can lead to serious injury and/or death. Posted 10/05/2012
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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.)Medication Guides
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) (formerly AERS) Postmarketing Drug and Biologic Safety Evaluations
Evaluations performed 18 months after drug approval, or after its use by 10,000 individuals.
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