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FDA: No harmful effects with brain retention of gadolinium-based contrast agents Findings contrast with those of European Medicines Agency

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EU group advises suspending market authorization for some gadolinium contrast agents

by Thomas Dworetzky , Contributing Reporter
Four MR contrast agents using gadolinium should have market authorizations stopped in Europe, according to the European Union's committee that weighs the risks of medicine.

The specific agents include:

  • Gadobenic acid, marketed under the trade name MultiHance by Bracco

  • Gadodiamide, sold under the trade name Omniscan by GE Healthcare

  • Gadopentetic acid, marketed as Magnevist by Bayer HealthCare Pharmaceuticals

  • Gadoversetamide, sold as Optimark by Guerbet

The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) concluded its “assessment of gadolinium agents used in body scans and recommends regulatory actions, including suspension for some marketing authorizations,” the group said in a statement.

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It found evidence of brain deposits of the agent in “small amounts” after MR body scans “but no signs of harm,” it noted.

PRAC called the the evidence of accumulation in the brain “convincing,” based on studies “directly measuring gadolinium in brain tissues and areas of increased signal intensity seen on MR scan images many months after the last injection of a gadolinium contrast agent.'

These recommendations next go to the Committee for Medicinal Products for Human Use (CHMP) for an opinion, which will be released when that body weighs in on the matter.

Despite finding gadolinium in the brain, stated PRAC, “no symptoms or diseases' have been reported associated with the agents," according to the group, which added that long-term side effect data on this issue is “limited.”

In addition, it advised that, “deposition of gadolinium in other organs and tissues has been associated with rare side effects of skin plaques and nephrogenic systemic fibrosis, a scarring condition in patients with kidney impairment. Furthermore, non-clinical laboratory studies have shown that gadolinium can be harmful to tissues.”

The four at issue are all linear agents that have “a structure more likely to release gadolinium,” the group advised.

Macrocyclics are more stable, and the committee has recommended using those instead, “at the lowest does that enhances images sufficiently to make diagnoses, and only when unenhanced body scans are not suitable.”

Not all linear agents would be taken off the shelves. PRAC noted that gadoxetic acid “can remain on the market, as it meets an important diagnostic need in patients with few alternatives. In addition, a formulation of gadopentetic acid injected directly into joints is to remain available because its gadolinium concentration is very low – around 200 times lower than those of intravenous products. Both agents should be used at the lowest dose that enhances images sufficiently to make diagnoses, and only if unenhanced scans are not suitable,” it recommended.
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