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
Baxa Corporation Abacus Total Parenteral Nutrition (TPN) Calculation Software: Class I Recall - Potential Dosing Errors Problems associated with mix-ups related to salt-based or ion-based ordering of electrolytes. Posted 05/25/2012 Dialysate Concentrates Used in Hemodialysis: Safety Communication - Alkali Dosing Errors Risk of elevated bicarbonate levels in patients undergoing hemodialysis, which can contribute to metabolic alkalosis, a significant risk factor associated with cardiopulmonary arrest, low blood pressure, hypokalemia, hypoxemia, hypercapnia, and cardiac... Franck’s Compounding Pharmacy Sterile Preparations: Reports of Fungal Endophthalmitis, Expanded Recall Recall of all products sold by Franck's since November 2011 due to the possibility of lack of sterility. Posted 05/24/2012 Hospira Carpuject Pre-filled Cartridges - Drug Alert: Products May Contain More Than the Intended Fill Volume Healthcare professionals should visually inspect and confirm that the cartridge contains the labeled fill volume before dispensing and again before administering to patients. Posted 05/23/2012 West Coast Nutritionals Dietary Supplement Products: Recall - Undeclared Drug Ingredient Products marketed as dietary supplements contains drug ingredient Tadalafil, which may interact with nitrates found in some prescription drugs and lower blood pressure to dangerous levels. Posted 05/21/2012
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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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