Guerbet concurs with the PRAC Recommendations on Gadolinium-based Contrast Agents
Princeton, NJ, 31 March 2017 – Guerbet LLC. takes note of the recent recommendations issued March 10, 2017 by the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC), on Gadolinium-based Contrast Agents - procedure under Article 31 of Directive 2001/83/EC.
In March 2016, the EMA initiated a review of the risk of gadolinium deposition in brain tissue following the repeated use of gadolinium contrast agents in patients undergoing magnetic resonance imaging (MRI) scans.1 After a nearly yearlong in depth review, the PRAC has identified linear agents as more likely to release gadolinium and has recommended the suspension of four linear agents from the market:
• MultiHance® (gadobenic acid) • Magnevist® (gadopentetic acid)
• Optimark® (gadoversetamide) • Omniscan™ (gadodiamide)
The PRAC recommendations1 were announced on March 10, 2017 as follows:
“EMA’s Pharmacovigilance and Risk Assessment Committee (PRAC) has recommended the suspension of the marketing authorisations for four linear gadolinium contrast agents because of evidence that small amounts of the gadolinium they contain 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 images from magnetic resonance imaging (MRI) body scans. (…)
The four agents recommended for suspension are referred to as linear agents. Linear agents have a structure more likely to release gadolinium, which can build up in body tissues.
Other agents, known as macrocyclic agents, are more stable and have a much lower propensity to release gadolinium. The PRAC recommends that macrocyclic agents2 be used at the lowest dose that enhances images sufficiently to make diagnoses and only when unenhanced body scans are not suitable.
Some linear agents will remain available: gadoxetic acid, a linear agent used at a low dose for liver scans, 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. (…)”
“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 [EMA’s] Committee for Medicinal Products for Human Use (CHMP) for its opinion. Further details will be published at the time of the CHMP opinion.”
Guerbet concurs with the PRAC recommendations and does not intend to request a re-examination of the recommendations.
2 Gadobutrol, gadoteric acid and gadoteridol