Other safety alerts
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| China: China Food and Drug Administration calls attention to concern about the risk of brain deposition caused by repeated use of gadolinium contrast agents |
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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 Jul 2015, with the latest update posted on 28 Jul 2017. Letters to inform local healthcare professionals were issued by the Department of Health (DH) on 24 Jul 2017. So far, the 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 previously reported, the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Please refer to the following Chinese website for details:
http://www.drugoffice.gov.hk/eps/news/../29736.html
Ends/Thursday, Dec 7, 2017
Issued at HKT 16:00
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