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
- April Safety Labeling Changes
Monthly Safety Labeling Changes includes 43 products with revisions to Prescribing Information. Posted 05/14/2012 Gilenya (fingolimod): Drug Safety Communication - Safety Review of a Reported Death After the First Dose UPDATED 05/14/2012. New recommendations for monitoring patients, and new contraindications, and dosing & administration information for use in certain patients. Originally posted 12/20/2011 Hydromorphone Hydrochloride Injection 1 MG/ML, (C-II) 1 ML Fill In 2.5 ML Carpuject: Recall - May Contain More Than the Intended Fill Volume An overdose of Hydromorphone may result in life-threatening consequences, including respiratory depression (slowed breathing or suspension of breathing), low blood pressure, and reduced heart rate including circulatory collapse. Posted 05/14/2012 Revlimid (lenalidomide): Ongoing Safety Review - Increased Risk of Developing New Malignancies UPDATED 05/07/2012. Increased risk of developing acute myelogenous leukemia, myelodysplastic syndromes, and Hodgkin lymphoma in patients being treated with Revlimid. Originally posted 04/08/2011
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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 Adverse Event Reporting System (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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