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
Gris-PEG (griseofulvin ultramicrosize): Health Advisory - Risk of Product Mix-Up During packaging and labeling, tablets from one product type may have carried over into packaging of another product. Posted 02/03/2012 Acetylcysteine Solution, USP (Roxane Laboratories, Inc.): Recall - Visible Glass Particle Use of an inhaled product with glass particles has the potential to cause choking which could be life-threatening. Posted 02/03/2012 Lo/Ovral-28 (Norgestrel/EthinylEstradiol) Tablets: Recall - Possibility of Inexact Tablet Counts or Out of Sequence Tablets Oral contraceptive daily regimen may be incorrect and could leave women without adequate contraception, and at risk for unintended pregnancy. Posted 02/01/2012 Vitaflo USA Renastart: Recall - Possible Health Risk Due To Incorrectly Labeled Cans Consequences of using the incorrectly labeled product may result in high potassium blood levels (hyperkalemia) or high sodium levels in the blood (hypernatremia). Posted 01/31/2012 Treanda (bendamustine HCL): Recall - Particulate Matter in Vial Potential adverse events after intravenous administration of solutions containing particulates may include emboli and result in disruption of blood flow, causing tissue/organ damage. Posted 01/30/2012
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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 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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