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FDA Warns About MRI Contrast Agents, But Other Regulators Have Taken Stricter Stances

STAT  reports in “Pharmalot” that the Food and Drug Administration “issued a warning about contrast agents used in MRI scans, over concerns they contain a potentially toxic metal that can be left in the brain tissue.” The article points out that regulators in other countries have “been far tougher on the issue,” as the UK’s National Health Service has “suspended two agents over the same concerns,” the European Medicine Agency has suspended three, and Japan “also restricted the use of some agents.”

MedPage Today reports that “gadolinium contrast agents used in magnetic resonance imaging (MRI) must now carry a warning about their retention in the body, which has been linked to adverse renal effects, the FDA said” yesterday. In a statement, Janet Woodcock, MD, director of the agency’s Center for Drug Evaluation and Research, said, “The FDA reviewed available data about the retention of gadolinium from gadolinium-based contrast agents as part of its role in monitoring the post-market safety of drugs.”

Medscape  reports that the agency “will also require a new medication guide that providers should give to patients in advance of receiving a GBCA.” Additionally, “GBCA manufacturers will be required to conduct further studies to assess the safety of this class of contrast agents.” Also covering the story are HealthDay and Aunt Minnie.

From the news release of the American Association for Justice.

Bob Kraft

I am a Dallas, Texas lawyer who has had the privilege of helping thousands of clients since 1971 in the areas of Personal Injury law and Social Security Disability.

About This Blog

The title of this blog reflects my attitude toward those government agencies and insurance companies that routinely mistreat injured or disabled people. As a Dallas, Texas lawyer, I've spent more than 45 years trying to help those poor folk, and I have been frustrated daily by the actions of the people on the other side of their claims. (Sorry if I offended you...)

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