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FDA Medwatch Alert: Gadolinium-based Contrast Agents for Magnetic Resonance Imaging (MRI): Drug Safety Communication - No Harmful Effects Identified With Brain Retention

Posted 23 May 2017 by Drugs.com

All GBCAs may be associated with some gadolinium retention in the brain and other body tissues. However, because FDA identified no evidence to date that gadolinium retention in the brain from any of the GBCAs, including GBCAs associated with higher retention of gadolinium, is harmful, restricting GBCA use is not warranted at this time. FDA will continue to assess the safety of GBCAs and plan to have a public meeting to discuss this issue in the future. Including: Ablavar (gadofosveset trisodium) Dotarem (gadoterate meglumine) Eovist (gadoxetate disodium) Gadavist (gadobutrol) Magnevist (gadopentetate dimeglumine) MultiHance (gadobenate dimeglumine) Omniscan (gadodiamide) OptiMARK (gadoversetamide) ProHance (gadoteridol) FDA evaluated scientific publications and adverse event reports submitted to FDA. Some human and animal studies looked at GBCA use over periods longer than a year. These ... Read more

Related support groups: Diagnosis and Investigation, Magnevist, OptiMARK, Eovist, Multihance, Gadavist, Gadobutrol, Gadopentetate Dimeglumine, Omniscan, Gadoterate Meglumine, Gadoversetamide, Gadofosveset Trisodium, Ablavar, Gadodiamide, Gadoteridol, Omniscan Safepak, Dotarem, Gadoxetate Disodium, Prohance, Vasovist

FDA Medwatch Alert: Gadolinium-based Contrast Agents for Magnetic Resonance Imaging (MRI): Drug Safety Communication - FDA Evaluating the Risk of Brain Deposits With Repeated Use

Posted 27 Jul 2015 by Drugs.com

ISSUE: FDA is investigating the risk of brain deposits following repeated use of gadolinium-based contrast agents (GBCAs) for magnetic resonance imaging (MRI). Recent publications in the medical literature have reported that deposits of GBCAs remain in the brains of some patients who undergo four or more contrast MRI scans, long after the last administration. It is unknown whether these gadolinium deposits are harmful or can lead to adverse health effects. FDA, including its National Center for Toxicological Research (NCTR), will study this possible safety risk further. FDA is working with the research community and industry to understand the mechanism of gadolinium retention and to determine if there are any potential adverse health effects. Based on the need for additional information, at this time, FDA is not requiring manufacturers to make changes to the labels of GBCA products. ... Read more

Related support groups: Diagnosis and Investigation, Magnevist, OptiMARK, Eovist, Multihance, Gadavist, Gadobutrol, Gadopentetate Dimeglumine, Omniscan, Gadoterate Meglumine, Gadoversetamide, Gadofosveset Trisodium, Ablavar, Gadodiamide, Gadoteridol, Omniscan Safepak, Dotarem, Gadoxetate Disodium, Prohance, Vasovist

Medicines Are Biggest Culprit in Fatal Allergic Reactions: Study

Posted 10 Oct 2014 by Drugs.com

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

Related support groups: Depo-Provera, Provera, Amoxicillin, Metronidazole, Doxycycline, Clindamycin, Cephalexin, Azithromycin, Methotrexate, Penicillin, Bactrim, Cipro, Accutane, Ciprofloxacin, Flagyl, Augmentin, Lupron, Levaquin, Keflex, Medroxyprogesterone

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