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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
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
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
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
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
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
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
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
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
Nationwide recall of Regeneca's entire line of herbal and dietary supplement products.
Posted: March 9, 2017, 6:40 pm
Laboratory results confirmed contamination with Pantoea and Enterococcus (intrinsically vancomycin-resistant) bacteria.
Posted: March 9, 2017, 4:00 pm
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
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