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FDA Approves Bayer's Gadavist (gadobutrol) Injection for use with Magnetic Resonance Angiography of Supra-Aortic Arteries

Posted 2 May 2016 by Drugs.com

WHIPPANY, N.J., April 29, 2016 /PRNewswire/ – Bayer announced today that the U.S. Food and Drug Administration (FDA) has approved Gadavist (gadobutrol) injection for use with magnetic resonance angiography (MRA) to evaluate known or suspected supra-aortic or renal artery disease in adult and pediatric patients (including term neonates).1 The FDA approval is based on the results of two, multi-center, Phase 3, open-label clinical studies – the GEMSAV study of patients with known, or suspected vascular disease, of the supra-aortic arteries and the GRAMS study of patients with known or suspected renal artery disease.1 "Until now, no contrast agents were FDA approved for use with MRA of the supra-aortic arteries," said Dr. Elias Melhem, M.D., Chair, Department of Diagnostic Radiology & Nuclear Medicine, University of Maryland, and principal investigator for the GEMSAV study. "With FDA's a ... Read more

Related support groups: Diagnosis and Investigation, Gadavist, Gadobutrol

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, Eovist, Gadavist, Multihance, Vasovist, Gadobenate Dimeglumine, Gadobutrol, Gadopentetate Dimeglumine, Gadoterate Meglumine, Omniscan, Gadoversetamide, OptiMARK, Gadofosveset Trisodium, Ablavar, Gadodiamide, Gadoteridol, Omniscan Safepak, Dotarem, Gadoxetate Disodium

FDA Approves Gadavist (gadobutrol) as the First MRI Contrast Agent for Patients Less Than 2 Years

Posted 7 Jan 2015 by Drugs.com

LEVERKUSEN, Germany, Jan. 5, 2015 /PRNewswire/ – Bayer HealthCare announced today that the U.S. Food and Drug Administration (FDA) has approved Gadavist (gadobutrol) injection for use with magnetic resonance imaging (MRI) in pediatric patients less than 2 years of age, including term neonates, to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system.1 Gadavist was previously approved for this use in patient populations over the age of 2. The FDA's priority review was based on a study showing that the pharmacokinetic (PK) and safety profiles in pediatric patients less than 2 years of age were similar to that of older children and adults at standard dose (0.1 mmol/kg).1 "Until this study, there were limited data regarding the use of gadolinium-based contrast agents in pediatric patients younger than 2 years of age, and ... Read more

Related support groups: Diagnosis, Diagnosis and Investigation, Body Imaging, Gadavist, Gadobutrol

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

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