ADR that result in revision of patient information
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| European Union: PRAC confirms restrictions on the use of linear gadolinium agents. Benefit-risk balance of certain linear gadolinium agents no longer favourable |
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The European Medicines Agency (EMA)’s Pharmacovigilance Risk Assessment Committee (PRAC) has confirmed its previous conclusion from March 2017 that there is convincing evidence of gadolinium deposition in brain tissues following use of gadolinium contrast agents. No specific conditions linked to gadolinium deposition in the brain have been identified, but the clinical consequences are unknown.
As a result of the review, the PRAC recommends that the intravenous linear agents gadoxetic acid and gadobenic acid should only be used for liver scans in the situations where they meet an important diagnostic need. In addition, gadopentetic acid should only be used for joint scans as the gadolinium concentration in the formulation used for joint injections is very low.
All other intravenous linear agents (gadodiamide, gadopentetic acid and gadoversetamide) should be suspended in line with the PRAC’s March 2017 recommendation.
Another class of gadolinium agents known as macrocyclic agents (gadobutrol, gadoteric acid and gadoteridol) are more stable and have a lower propensity to release gadolinium than linear agents. These can continue to be used in their current indications but in the lowest doses that enhance images sufficiently and only when unenhanced body scans are not suitable.
The review has been carried out by the PRAC which made a set of recommendations in March 2017. Following a request from companies concerned, the PRAC re-examined its initial recommendation. The PRAC’s final recommendations will now be sent to the Committee for Medicinal Products for Human Use (CHMP), which will adopt the Agency’s opinion.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/docs/en_GB/../WC500230928.pdf
In Hong Kong, there are 8 registered pharmaceutical products which are gadolinium contrast agents, and are prescription only medicines, including Magnevist Inj (HK-32608) containing meglumine gadopentetate, Omniscan Inj 0.5mmol/ml (HK-43493) containing gadodiamide, Gadovist Inj 1mmol/ml (HK-51750) and Gadovist Inj 1mmol/ml (Prefilled Syringe) (HK-57330) containing gadobutrol, Primovist Prefilled Syringe Inj 0.25mmol/ml (HK-54116) containing sodium gadoxetate, Dotarem Inj 377mg/ml (Vial) (HK-41578) and Dotarem Prefilled Syringes 377mg/ml (HK-41579) containing meglumine gadoterate, and MultiHance Inj 334mg (HK-57789) containing gadobenic acid (as meglumine gadobenate).
Related news was previously issued by various overseas drug regulatory authorities, and was posted on the Drug Office website since 28 July 2015, with the latest update posted on 23 May 2017. So far, the Department of Health (DH) has received 7 cases of adverse drug reaction (ADR) in connection with gadolinium contrast agents: 2 cases on Omniscan, 3 cases on Dotarem, and 2 cases on Gadovist, but all these ADR cases were not related to gadolinium deposition in brain tissues. As the PRAC’s recommendations will now be sent to the EMA's CHMP for final adoption, DH will continue to remain vigilant on the safety updates of gadolinium contrast agents by other overseas drug regulatory authorities.
Ends/Saturday, Jul 8 2017
Issued at HKT 15:00
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