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
August 2012 August 2012 Safety Labeling Changes includes 53 products with revisions to Prescribing Information Over-The-Counter Topical Muscle and Joint Pain Relievers: Drug Safety Communication - Rare Cases of Serious Burns Some of the burns had serious complications requiring hospitalization Posted 09/13/2012 Qualitest Hydrocodone Bitartrate and Acetaminophen Tablets 10 mg/500 mg: Recall - Potential for Oversized Tablets Tablets from the affected lot may exceed the weight specification and could be super-potent for the ingredients Hydrocodone Bitartrate and Acetaminophen. Posted 09/11/2012 Nimodipine: Recall - Crystallization of Fill Material The product may no longer be bioequivalent and may potentially affect patients who are being treated for a medical emergency. Posted 09/05/2012 I-Flow ON-Q Pump with ONDEMAND Bolus Button: Class I Recall - Risk of Continuous Infusion at a Rate Greater Than Expected Bolus Button may not lock in the down position when depressed and/or the orange bolus refill indicator may stay in the lowest most position, which can lead to serious adverse health consequences, including death. Posted 08/31/2012 EphBurn 25 Dietary Supplement by Brand New Energy: Recall - Undeclared Drug Ingredient Adverse effects associated with ephedrine alkaloid-containing supplements may include elevated blood pressure, rapid heartbeat, nerve damage, muscle injury, psychosis, memory loss, heart attack, stroke, seizure and death. Posted 08/31/2012
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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 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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