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FDA Medwatch Alert: Iodine-containing Contrast Agents for Medical Imaging: Drug Safety Communication - Rare Cases of Underactive Thyroid in Infants

Posted 17 Nov 2015 by

ISSUE: FDA is advising that rare cases of underactive thyroid have been reported in infants following the use of contrast media containing iodine, also called “contrast dye,” for X-rays and other medical imaging procedures. In all of the reported cases, the infants were either premature or had other serious underlying medical conditions. Available evidence leads FDA to believe that this rare occurrence is usually temporary and resolves without treatment or any lasting effects. See the Drug Safety Communication for a data summary and a list of approved Approved Iodinated Contrast Media Products. FDA approved changes to the labels of all iodinated contrast media (ICM) products to include information about these cases. No changes to current prescribing, administration, or monitoring practices are recommended. FDA will continue to evaluate this issue and will update the public when there is ... Read more

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Medicines Are Biggest Culprit in Fatal Allergic Reactions: Study

Posted 10 Oct 2014 by

THURSDAY, Oct. 9, 2014 – Although food allergies have garnered a lot of attention lately, a new study reports that medications are actually the biggest cause of sudden deaths related to allergy. Over a little more than a decade, nearly 60 percent of the allergy-related deaths were caused by medications, while less than 7 percent were caused by food allergies, the study found. "Medications can be dangerous," said study researcher Dr. Elina Jerschow, director of the Drug Allergy Center at Montefiore Medical Center and assistant professor of medicine at Albert Einstein College of Medicine, in New York City. While research from other countries has reported medications as a major culprit in anaphylaxis-related deaths, Jerschow said, the problem has been less defined in the United States. One reason is that there is no national registry for anaphylaxis deaths, she said. The study was ... Read more

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FDA Medwatch Alert: Ultravist (iopromide) Injection 370mgl/mL, 125 mL

Posted 21 Jul 2006 by

[UPDATED 07/31/2006] Berlex, Inc. and FDA announced a voluntary worldwide recall of all lots of Ultravist (iopromide) Injection 370mgl/mL, 125 ml, due to the presence of particulate matter and crystallization with the potential for thromboembolic safety problems if an affected product is administered to patients. [Posted 07/21/2006] Berlex, Inc. and FDA announced a voluntary nationwide recall of a single lot (No. 41500A, Exp. 1/2007) of Ultravist (iopromide) Injection 370mgl/mL, 125 ml, an intravenous X-ray contrast agent, due to the presence of particulate matter in conjunction with crystallization. The product was recalled because of the potential for serious safety problems if Ultravist Injection is administered to patients. These problems may include thrombosis of blood vessels, thromboembolism and injury or infarction of end organs such as heart, kidney, and brain. Hospitals, ... Read more

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Peripheral Arteriography, Cerebral Arteriography, Computed Tomography, Coronary Arteriography, Intra-arterial Digital Subtraction Angiography, Left Ventriculography, Urography, Venography

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