Thu, 12 Jan 2017 09:00:00 -0500
Consumers who use a contaminated product are at risk for serious, potentially life-threatening infections.
Wed, 11 Jan 2017 17:30:00 -0500
The particulate matter could enter into the patient and cause serious adverse health consequences including infection, damage of tissue, and death.
Wed, 11 Jan 2017 10:50:00 -0500
Reports of serious adverse events, including patient injury & death, describing medication dosing inaccuracies and other mechanical problems with pumps after an MRI exam.
Mon, 09 Jan 2017 00:00:00 -0500
These vulnerabilities, if exploited, could allow an unauthorized user to remotely access a patient's RF-enabled implanted cardiac device by altering the Merlin@home Transmitter.
Fri, 23 Dec 2016 09:35:00 -0500
IgM tests remain useful in ruling out Zika exposure, but require confirmatory testing. Do not rely on presumptive positive Zika virus IgM test results as the sole basis of significant patient management decisions.
Tue, 20 Dec 2016 10:00:00 -0500
Non-sterile surgical devices can lead to infections, and other serious adverse health consequences, including death.
Fri, 16 Dec 2016 12:01:00 -0500
FDA determined the risk of serious side effects on mood, behavior, or thinking is lower than previously suspected.
Wed, 14 Dec 2016 12:01:00 -0500
Published studies in pregnant animals and young animals have shown the use of general anesthetic and sedation drugs for more than 3 hours caused widespread loss of nerve cells in the brain.
Mon, 12 Dec 2016 15:05:00 -0500
FDA approved label updates to describe additional studies reviewed.
Fri, 09 Dec 2016 15:30:00 -0500
Excess material may separate from catheter during use and enter patient’s bloodstream, resulting in serious adverse health consequences such as blood clots, embolism of the excess material to vital organs, or death.
Thu, 01 Dec 2016 08:40:00 -0500
Undeclared tadalafil and sildenafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels.
Thu, 01 Dec 2016 08:15:00 -0500
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.
Sat, 26 Nov 2016 10:00:00 -0500
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.
Fri, 25 Nov 2016 00:00:00 -0500
The homeopathic products have a very small amount of belladonna, a substance that can cause harm at larger doses.
Tue, 22 Nov 2016 14:50:00 -0500
Can lead to serious adverse health consequences including embolism, stroke, or death.
Mon, 21 Nov 2016 15:00:00 -0500
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.
Mon, 21 Nov 2016 12:30:00 -0500
Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening.
Fri, 18 Nov 2016 14:00:00 -0500
People who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction.
Tue, 15 Nov 2016 12:10:00 -0500
Essure labeling now includes the addition of a boxed warning and a Patient Decision Checklist.
Tue, 08 Nov 2016 15:50:00 -0500
Undeclared sibutramine, desmethylsibutramine, and/phenolphthalein present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.
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