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
Ameridose, LLC: Recall of Unexpired Products in Circulation FDA’s preliminary findings have raised concerns about a lack of sterility assurance for products produced at and distributed by this facility. Posted 10/31/2012 Classic Zi Xiu Tang Bee Pollen Capsules And Ultimate Formula Capsules by Zi Xiu Tang Success: Recall - Undeclared Sibutramine Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. Posted 10/31/2012 Hospira Symbiq Infusion System Touchscreen: Class 1 Recall - May Not Respond to Selection Failure of touchscreen to respond to user input could result in a delay or interruption in therapy or over delivery or under delivery of medication. Posted 10/29/2012 Ethicon Endo-Surgery Circular Stapler Sets: Class I Recall - User Difficulty With Firing Stapler Devices Failure to complete the firing stroke of the stapler can result in severe pain, sphincter dysfunction, rectal wall damage, sepsis, bleeding, and occlusion of the rectal canal. Posted 10/26/2012 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 UPDATE 10/26/2012. Class I recall of the Stryker Neptune Rover Waste Management Systems. Originally posted 10/05/2012 Over-The-Counter Eye Drops and Nasal Sprays: Drug Safety Communication - Serious Adverse Events From Accidental Ingestion by Children Accidental ingestion of active ingredients tetrahydrozoline, oxymetazoline, or naphazoline may cause serious and life-threatening adverse events. Posted 10/25/2012 Fungal Meningitis Outbreak UPDATED 10/24/2012. The updated list of customers (consignees) who were shipped product on or after May 21, 2012 from the New England Compounding Center’s (NECC) Framingham, MA facility is now posted. September 2012 Safety Labeling Changes includes 61 products with revisions to Prescribing Information. Posted 10/17/2012
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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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