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FDA MedWatch Safety Alerts
Mislabeled product could expose the consumer or their pet(s) to potential overdosing that can cause severe intoxication which may lead to cardiogenic shock, renal failure, coma or death.
Posted: April 21, 2017, 6:10 pm
Codeine and Tramadol Medicines: Drug Safety Communication - Restricting Use in Children, Recommending Against Use in Breastfeeding Women
New and strengthened WARNINGS and CONTRAINDICATIONS on drug labels describing serious risks, including slowed or difficult breathing and death.
Posted: April 20, 2017, 3:30 pm
Use of these products may pose a threat to consumers because the undeclared ingredients may interact with nitrates found in some prescription drugs and may lower blood pressure to dangerous levels.
Posted: April 19, 2017, 12:55 pm
Updated 04/13/2017. Homeopathic teething products containing belladonna pose an unnecessary risk to infants and children.
Posted: April 13, 2017, 11:00 pm
StrataMR Adjustable Valves and Shunts by Medtronic: Recall - Potential for Under-Drainage of Cerebrospinal Fluid
If left untreated, under-drainage can potentially lead to coma and death.
Posted: April 9, 2017, 1:29 am
Voluntary recall of all lots of sterile products, to the hospital/user level.
Posted: April 6, 2017, 8:35 pm
Newport HT70 and HT70 Plus Ventilators by Medtronic: Field Corrective Action - Ventilator May Reset Spontaneously
Potential for ventilator reset during normal operation, without an accompanying alarm.
Posted: April 5, 2017, 5:40 pm
Failure to activate or increased force needed to activate may have significant health consequences for a patient experiencing a life-threatening allergic reaction (anaphylaxis).
Posted: March 31, 2017, 11:00 pm
Prelude Short Sheath Introducer by Merit Medical Systems: Class I Recall - Sheath May Separate During Use
Tip could enter the patient's bloodstream, resulting in prolonged procedure times, additional surgery to remove the tip from the patient, blood clots, internal tears and perforation to arteries or veins, excessive bleeding, and death.
Posted: March 31, 2017, 5:30 pm
Sibutramine may substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.
Posted: March 30, 2017, 1:50 pm
A delay in delivering therapy could result in serious patient injury such as permanent organ damage, brain injury, or death.
Posted: March 24, 2017, 5:20 pm
BIA-ALCL is a rare condition; when it occurs, it has been identified most frequently in patients undergoing implant revision operations for late onset, persistent seroma.
Posted: March 21, 2017, 5:00 pm
Absorb GT1 Bioresorbable Vascular Scaffold (BVS) by Abbott Vascular: Letter to Health Care Providers - FDA Investigating Increased Rate of Major Adverse Cardiac Events
Increased rate of major adverse cardiac events observed in patients receiving the BVS, when compared to patients treated with metallic XIENCE drug-eluting stent.
Posted: March 18, 2017, 2:00 pm
Viberzi (eluxadoline): Drug Safety Communication - Increased Risk of Serious Pancreatitis In Patients Without A Gallbladder
Patients who do not have a gallbladder should not take Viberzi. Developing pancreatitis could result in hospitalization or death.
Posted: March 15, 2017, 4:02 pm
SynchroMed II and SynchroMed EL Implantable Drug Infusion Pumps by Medtronic: Class I Recall - Failure of Priming Bolus
Patients may receive a drug overdose or under dose which can lead to serious adverse health consequences such as respiratory depression, coma or death.
Posted: March 14, 2017, 5:20 pm
Lifepak 1000 Defibrillators by Physio-Control: Voluntary Field Action - Immediately Remove and Reinstall Battery
Device has shut down unexpectedly during patient treatment, which may expose patients to the risk of serious harm or death. Posted 01/14/2017
Posted: March 9, 2017, 7:23 pm
Herbal and Dietary Supplement Products by Regeneca Worldwide: Recall - Not Manufactured in Compliance with Current Good Manufacturing Practices
Nationwide recall of Regeneca's entire line of herbal and dietary supplement products.
Posted: March 9, 2017, 6:40 pm
SPS-1 Static Preservation Solution distributed by Organ Recovery Systems: Safety Communication - FDA Warns Of Potential Contamination
Laboratory results confirmed contamination with Pantoea and Enterococcus (intrinsically vancomycin-resistant) bacteria.
Posted: March 9, 2017, 4:00 pm
Balloon angioplasty devices to treat autonomic dysfunction: FDA Safety Communication - FDA concern over experimental procedures
Procedure may put patients at risk because is being promoted as treatment for a variety of conditions even though it has not been formally studied in clinical trials
Posted: March 8, 2017, 6:30 pm
Dietary Supplements for Male Sexual Enhancement by A and H Focal: Recall - Undeclared Drug Ingredient
PDE-5 Inhibitors may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels.
Posted: March 8, 2017, 1:00 am