European Medicines Agency suspends some gadolinium agents from market

Published: 23 March 2017 Ezine

The European Medicines Agency’s Pharmacovigilance and Risk Assessment Committee (PRAC) has recommended the suspension of the marketing of four linear gadolinium contrast agents.

A review by the PRAC found evidence that small amounts of the gadolinium contained in the agents are deposited in the brain.

The agents concerned are intravenous injections of gadobenic acid, gadodiamide, gadopentetic acid and gadoversetamide, which are given to patients to enhance MR images.

These are also commonly known as:

  • MultiHance
  • Omniscan
  • Magnevist
  • OptiMARK

The companies concerned by this review have the right to request the PRAC to re-examine its recommendations.

The PRAC’s final recommendations will be sent to the Committee for Medicinal Products for Human Use (CHMP) for its opinion. Further details will be published at the time of the CHMP opinion.

Although no symptoms or diseases linked to gadolinium in the brain have been reported, the PRAC has taken a precautionary approach.

You can read more on the EMA website.

Further updates will be posted on our MR web pages.