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
New England Compounding Center (NECC) Potentially Contaminated Medication: Fungal Meningitis Outbreak FDA has observed fungal contamination by direct microscopic examination of foreign matter taken from a sealed vial of methylprednisolone acetate. Posted 10/05/2012 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 Incorrect use can cause hemorrhaging and soft tissue, muscle, and vital organ damage, which can lead to serious injury and/or death. Posted 10/05/2012 H & P Industries Povidone Iodine Swabsticks, Prep Solutions, Scrub Solutions, and Prep Gel: Recall - Inadequate Microbial Testing [UPDATED 09/25/2012] Custom Medical Specialties, Inc., HSG Tray, Hysteroscopic Sterilization Pack, Vein Tray, Amnio Tray, Fox Chase Specials Pack, Abington Radiology Drainage Pack, CT Biopsy Tray, Myelogram Tray, and Hysteroscopy Sterile Procedure... Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/500 mg (Watson Laboratories): Recall - Potential for Oversized and Superpotent Tablets Ingestion of excessive amounts of acetaminophen may result in liver toxicity, severe liver damage, or death. Posted 09/24/2012 Mojo Nights and Mojo Nights for Her: Recall - Undeclared Drug Ingredient Product marketed as dietary supplement contains drug ingredients tadalafil and sildenafil, which may interact with nitrates found in some prescription drugs and lower blood pressure to dangerous levels. Posted 09/21/2012 Mirapex (pramipexole): Drug Safety Communication - Ongoing Safety Review, Possible Risk of Heart Failure FDA currently evaluating analysis of randomized clinical trials and epidemiologic studies. Posted 09/19/2012 Intestinomicina (contains chloramphenicol) by Laboratorios Lopez: Safety Alert - Contains Drug Ingredient Withdrawn from US Intestinomicina contains chloramphenicol, drug ingredient withdrawn from the US due to the risk of serious and life threatening injuries. Posted 09/18/2012
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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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