FDA Medical Watch Alerts

List of FDA Medical Watch Alerts

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Date Reported	Drug Name	Status
07/09/2015	Non-aspirin Nonsteroidal Anti-inflammatory Drugs (NSAIDs): Drug Safety Communication - FDA Strengthens Warning of Increased Chance of Heart Attack or Stroke	Patients and health care professionals should remain alert for heart-related side effects the entire time that NSAIDs are being taken.
07/02/2015	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.
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.
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.
07/01/2015	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.
06/24/2015	Daytrana Patch (methylphenidate transdermal system): Drug Safety Communication - Permanent Skin Color Changes	New warning added to drug label to describe risk of chemical leukoderma. chemical leukoderma, have been associated with the use of the Daytrana patch.
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.
06/24/2015	Daytrana Patch (methylphenidate transdermal system): Drug Safety Communication - Permanent Skin Color Changes	New warning added to drug label to describe risk of chemical leukoderma. chemical leukoderma, have been associated with the use of the Daytrana patch.
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.
06/22/2015	HeartWare Ventricular Assist System: Class I Recall – Updated with Multiple Reasons for Recall	FDA will update recall with new information as it becomes available.

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Last updated on June 27, 2015