Medicine recalls
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| The United Kingdom: Class 2 Medicines Recall: Magnevist and Omniscan Solutions for injection |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that Bayer plc and GE Healthcare AS are recalling batches of Magnevist Solution for injection, 0.5mmol/ml, intravenous (Gadopentetate Dimeglumine) and Omniscan Solutions for injection 0.5mmol/ml (Gadodiamide) following a safety review of the gadolinium containing contrast media by the European Medicines Agency (EMA).
All unexpired stock of the above products marketed by Bayer plc and GE Healthcare AS is being recalled and should immediately be quarantined. This follows a safety review of the gadolinium containing contrast media by the EMA which has resulted in the suspension of the above licences as of 1 Feb 2018.
The review concluded that small amounts of gadolinium are retained in brain tissue after the use of gadolinium contrast agents. More gadolinium retention in the brain has been observed with linear gadolinium agents than with macrocyclic gadolinium agents. Both of the products being recalled are linear agents. There is currently no evidence that gadolinium deposition in the brain has caused any adverse neurological effects in patients.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-2-medicines-recall-magnevist-and-omniscan-solutions-for-injection-el-18-a-02
In Hong Kong, Magnevist Inj (HK-32608) is a pharmaceutical product registered by Bayer Healthcare Ltd, and Omniscan Inj 0.5mmol/ml (HK-43493) is a product registered by GE Medical Systems Hong Kong Ltd. Both products are prescription-only medicines.
News related to gadolinium retention of gadolinium-containing contrast agents 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 16 Jan 2018. Letters to inform local healthcare professionals were issued by the Department of Health (DH) on 24 Jul 2017. So far, the DH has not received any case of adverse drug reaction related to Magnevist; while has received 2 cases related to Omniscan but these 2 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.
Ends/Friday, Feb 2, 2018
Issued at HKT 15:00
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