Safety
-
?
-
Resources for You
-
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. |
-
What's New
Vistide (Cidofovir Injection) by Gilead: Recall - Presence Of Particulate Matter The effects from intravenous injection of products with particulate matter can vary depending on the amount of particulate matter injected into the patient. Posted 02/16/2013 GE Healthcare, LLC, Giraffe and Panda T-Piece Resuscitation Systems and Mask Resuscitation Systems: Class 1 Recall - Potential reversal of oxygen/air Potential reversal of oxygen/air concentrations may cause serious adverse health consequences, including death. Posted 02/14/2013 St. Jude Medical, AMPLATZER TorqVue FX Delivery System: Class I Recall - Core Wire May Fracture Core wire fracture may lead to serious adverse health consequences, including death. Posted 02/13/2013 January 2013 Safety Labeling Changes includes 27 products with revisions to Prescribing Information. Posted 02/08/2013 Hamilton Medical, Inc., HAMILTON-T1 Ventilators with Software Versions 1.1.2 and Lower Possible miscalculation of oxygen supply Posted 02/07/2013
-
-
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) Postmarket Drug and Biologic Safety Evaluations
Evaluations performed 18 months after drug approval, or after its use by 10,000 individuals.
-
?
?
?
-
-