Your FDA gateway for clinically important safety information and reporting serious problems with human medical products.
RotaWire Elite Guidewire and wireClip Torquer Guidewire by Boston Scientific: Recall - Wires May Break and Separate from the Rotablator System The use of affected product may cause serious adverse health consequences, including death. Posted 11/27/2015 Compounded Multivitamins by Glades Drugs: Voluntary Recall - High Amounts of Vitamin D3 (Cholecalciferol) Consumption of this product may result in vitamin D toxicity, which may be severe and may lead to life-threatening outcomes if left untreated. Posted 11/25/2015 Intravascular Medical Devices: FDA Safety Communication - Lubricious Coating Separation Serious adverse events reported, including pulmonary embolism, pulmonary infarction, myocardial embolism, myocardial infarction, embolic stroke, tissue necrosis, and death. Posted 11/23/2015 Clozapine: Drug Safety Communication - FDA Modifies Monitoring for Neutropenia; Approves New Shared REMS Program UPDATED 11/19/2015: Clozapine REMS deadlines for prescribers and pharmacies extended. Originally posted 09/15/2015 Iodine-containing Contrast Agents for Medical Imaging: Drug Safety Communication - Rare Cases of Underactive Thyroid in Infants Labels of all iodinated contrast media (ICM) products will include information about these cases. No changes to current prescribing, administration, or monitoring practices are recommended. Posted 11/17/2015 Endoscope Washer/Disinfectors by Custom Ultrasonics: Safety Communication - FDA Recommends Health Care Facilities Transition to Alternate Reprocessing Methods Identified facility violations could result in an increased risk of infection transmission. Posted 11/13/2015 October 2015 Drug Safety Labeling Changes includes 26 products with revisions to Prescribing Information. Posted 11/13/2015 G5 Ventilator by Hamilton: Class I Recall - Ventilation and Alarm Failure If failure occurs, and the operator does not intervene, the patient may not receive enough oxygen and could suffer serious adverse health consequences, including injury or death. Posted 11/13/2015
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.)
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) Postmarket Drug and Biologic Safety Evaluations
Evaluations performed 18 months after drug approval, or after its use by 10,000 individuals.