ADR that result in revision of patient information
|
| |
| The United Kingdom: Gadolinium-containing contrast agents: Omniscan and iv Magnevist no longer authorised, MultiHance and Primovist for use only in liver imaging |
| |
Medicines and Healthcare products Regulatory Agency (MHRA) announces that a recent Drug Safety Update article in Dec 2017 advised that the licences for gadodiamide (Omniscan) and intravenous gadopentetic acid (also known as gadopentetate dimegulumine; Magnevist) will be suspended from 1 Feb 2018.
Omniscan and intravenous Magnevist are now no longer authorised for use and a product recall of any existing unexpired stock is underway.
The linear agents gadobenic acid (also known as gadobenate dimeglumine; MultiHance) and gadoxetic acid (Primovist) should now only be used for liver imaging and when imaging in the delayed phase is required.
Macrocyclic agents gadoteridol (Prohance), gadobutrol (Gadovist), and gadoteric acid (Dotarem) remain authorised, as does gadopentetic acid for intra-articular use only.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-safety-update/gadolinium-containing-contrast-agents-omniscan-and-iv-magnevist-no-longer-authorised-multihance-and-primovist-for-use-only-in-liver-imaging
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 2 Feb 2018. 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.
Ends/Wednesday, Feb 7, 2018
Issued at HKT 16:00
|
| |
|
