VILLEPINTE, France, March 13, 2017 /PRNewswire/ --
Guerbet (FR0000032526 GBT), a global specialist in contrast products and solutions for medical imaging, today notes the recommendations issued by the Pharmacovigilance Risk Assessment Committee (PRAC), on Gadolinium-based Contrast Agents - procedure under Article 31 of Directive 2001/83/EC.
(Logo: http://photos.prnewswire.com/prnh/20150917/267672LOGO )
On March 17, 2016, the European Medicines Agency (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 carrying out an almost year-long in-depth review of the risk of brain deposits and of the overall safety of these products, the PRAC recommendations are 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 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 agents[2] 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 low doses 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 Committee for Medicinal Products for Human Use (CHMP) for the adoption of EMA's final opinion. Further details will be published at the time of the CHMP opinion. »
Guerbet markets Dotarem® (gadoteric acid), an ionic macrocyclic gadolinium-based contrast agent, associated with high thermodynamic and kinetic stabilities[3],[4] and Optimark® (gadoversetamide), a non-ionic linear gadolinium-based contrast agent.
Guerbet takes good note of, and agrees with, the PRAC recommendations and fully cooperates in total transparency with the Health Authorities for Pharmacovigilance investigations. Consistently acting in the best interests of the patients is a fundamental principle at Guerbet.
--------------------------------------------------
1. http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Gadolinium-containing_contrast_agents/human_referral_prac_000056.jsp&mid=WC0b01ac05805c516f
2. Gadobutrol, gadoteric acid and gadoteridol
3. Morcos, S.K., Extracellular gadolinium contrast agents: differences in stability. Eur J Radiol, 2008. 66(2): p. 175-9.
4. Perazella, M.A. and R.A. Rodby, Gadolinium use in patients with kidney disease: a cause for concern. Semin Dial, 2007. 20(3): p. 179-85.
At Guerbet, we are strongly committed to providing healthcare professionals with a comprehensive range of effective and safe contrast media to improve diagnosis, prognosis and quality of life for patients.
About Guerbet
Guerbet is a pioneer in the contrast agent field, with 90 years' experience, and is the only pharmaceutical group dedicated to medical imaging worldwide. It offers a comprehensive range of X-Ray, Magnetic Resonance Imaging (MRI) and Interventional Radiology and Theranostics (IRT) products, along with a range of injectors and related medical devices to improve the diagnosis and treatment of patients. To discover new products and ensure future growth, Guerbet invests heavily in R&D on which it spends around 9% of its sales each year. Guerbet (GBT) is listed on Euronext Paris (Segment B - Mid Caps) and generated €776 million in revenue in 2016.
For more information about Guerbet, please visit http://www.guerbet.com/
