Safety
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Resources for You
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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
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 and Patient Death UPDATE 03/15/2013. Continued reports of serious tissue damage and patient death. Originally posted 10/05/2012 Incretin Mimetic Drugs for Type 2 Diabetes: Early Communication - Reports of Possible Increased Risk of Pancreatitis and Pre-cancerous Findings of the Pancreas Unpublished new findings by a group of academic researchers suggest an increased risk of pancreatitis and pre-cancerous cellular changes called pancreatic duct metaplasia. Posted 03/14/2013 February Safety Labeling Changes Safety Labeling Changes includes 35 products with revisions to Prescribing Information. Posted 03/12/2013 Azithromycin (Zithromax or Zmax): Drug Safety Communication - Risk of Potentially Fatal Heart Rhythms FDA is warning the public that azithromycin can cause abnormal changes in the electrical activity of the heart that may lead to a potentially fatal irregular heart rhythm. Posted 03/12/2013 Night Bullet: Recall - Undeclared Drug Ingredient Product marketed as dietary supplement contains drug ingredients Sulfohydroxyhomosildenafil and Aminotadalafil, which may interact with nitrates found in some prescription drugs and lower blood pressure to dangerous levels. Posted 03/12/2013 Ad-Tech Macro Micro Subdural Electrodes: Class 1 Recall-Potential for Abrasion of Brain Class 1 recall due to concern the microelectrodes are defective and may cause injury to the brain. Posted 03/07/2013
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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) Postmarket Drug and Biologic Safety Evaluations
Evaluations performed 18 months after drug approval, or after its use by 10,000 individuals.
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