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.
Lifesaver Single Patient Use Manual Resuscitator by Teleflex Hudson RCI: Class I Recall - Intake Port Blockage Recalled device may not deliver breathing support to the patient. A delay in treatment may potentially lead to patient injury or death. Posted 07/02/2015 FLOW-i Anesthesia Systems by Maquet: Class I Recall - Dislodged Patient Cassette May Stop Patient Ventilation May cause anesthesia gas to leak and could prevent the ventilator from providing breathing support if not corrected immediately. Posted 07/01/2015 Unapproved Prescription Ear Drop (Otic) Products: Not FDA Evaluated for Safety, Effectiveness and Quality Unapproved products may be contaminated or manufactured incorrectly, which could result in patients receiving the wrong dose, even when administered according to the labeled directions for use. Posted 07/01/2015 Codeine Cough-and-Cold Medicines in Children: Drug Safety Communication - FDA Evaluating Potential Risk of Serious Side Effects FDA investigating the safety of codeine-containing medicines to treat coughs and colds in children under 18 years because of the potential for slowed or difficult breathing. Posted 07/01/2015 Daytrana Patch (methylphenidate transdermal system): Drug Safety Communication - Permanent Skin Color Changes New warning added to drug label to describe risk of chemical leukoderma. Posted 06/24/2015 Covidien Shiley Neonatal and Pediatric Tracheostomy Tubes by Medtronic: Recall - Tubes Formed With Wider-angle Bend Than Standard Models Reports of 12 serious patient injuries, including breathing difficulties that impacted oxygen levels in patients. Posted 06/24/2015 HeartWare Ventricular Assist System: Class I Recall – Updated with Multiple Reasons for Recall FDA will update recall with new information as it becomes available. Posted 06/22/2015 M/L Taper with Kinectiv Technology Prosthesis by Zimmer: Class I Recall - Higher than Expected Levels of Manufacturing Residues Can cause serious adverse health issues including allergic reactions, pain, infections, or death. Posted 06/19/2015
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.