Follow us:

MedWatch Safety Alerts

MedWatch Safety Alert RSS Feed

FDA MedWatch Safety Alerts

Undeclared tadalafil and sildenafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels.
Posted: December 1, 2016, 1:40 pm
Sibutramine is known to 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: December 1, 2016, 1:15 pm
DMAA can narrow blood vessels and arteries, which can cause a rise in blood pressure or other cardiovascular problems such as shortness of breath, arrhythmias, tightening in the chest, and heart attack.
Posted: November 26, 2016, 3:00 pm
The homeopathic products have a very small amount of belladonna, a substance that can cause harm at larger doses.
Posted: November 25, 2016, 5:00 am
Can lead to serious adverse health consequences including embolism, stroke, or death.
Posted: November 22, 2016, 7:50 pm
Administration of a drug product intended to be sterile that has microbial contamination has the potential to result in serious infections which may be life-threatening.
Posted: November 21, 2016, 8:00 pm
Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening.
Posted: November 21, 2016, 5:30 pm
People who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction.
Posted: November 18, 2016, 7:00 pm
Essure labeling now includes the addition of a boxed warning and a Patient Decision Checklist.
Posted: November 15, 2016, 5:10 pm
Undeclared sibutramine, desmethylsibutramine, and/phenolphthalein present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.
Posted: November 8, 2016, 8:50 pm
Acute lead poisoning may cause abdominal pain, muscle weakness, nausea, vomiting, diarrhea, weight loss, and bloody or decreased urinary output. Long term exposure can lead to permanent damage to the central nervous system. Posted 11/08/2016
Posted: November 8, 2016, 2:15 pm
Loose power connector may allow moisture to enter the controller causing corrosion, electrical issues, reduced speaker volume and connection failures.
Posted: October 28, 2016, 6:45 pm
The most recent post-approval study results assessing post-market performance is available.
Posted: October 26, 2016, 3:00 pm
New Warning and updated Abuse and Dependence sections of labeling, including new safety information from published literature and case reports.
Posted: October 25, 2016, 4:29 pm
Contamination of the driveline may result in fluid or other material entering the pump and causing electrical issues or pump stops that may lead to serious adverse health consequences, including death.
Posted: October 24, 2016, 4:00 am
Connector detachment during use can deprive patient of adequate ventilation and require immediate medical intervention.
Posted: October 20, 2016, 6:00 pm
The FDA is concerned that health care providers may be unaware of the risks associated with these devices.
Posted: October 20, 2016, 1:30 pm
PTFE in the blood stream, based on the size and quantity, could lead to a thromboembolic event.
Posted: October 18, 2016, 4:01 pm
User may not be able to connect electrodes to Welch Allyn AED model 10 defibrillator, which may result in a delay in delivering the electrical therapy.
Posted: October 14, 2016, 6:30 pm
New information about M. chimaera infections, and updated recommendations to help prevent the spread of infection.
Posted: October 13, 2016, 7:00 pm