ADR that result in revision of patient information
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| The United States: FDA Drug Safety Communication: FDA warns that gadolinium-based contrast agents (GBCAs) are retained in the body; requires new class warnings: Update |
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The US Food and Drug Administration (FDA) announces an update to the Drug Safety Communication on gadolinium-based contrast agents (GBCAs). In addition to approving the updated prescribing information concerning the gadolinium retention safety issues, FDA has also approved new patient Medication Guides for all GBCAs.
Healthcare professionals and patients can access the patient Medication Guides according to the GBCA drug name on the Medication Guides webpage, or the latest prescribing information by searching in Drugs@FDA.
All MRI centers should provide a Medication Guide the first time an outpatient receives a GBCA injection or when the information is substantially changed. In general, hospital inpatients are not required to receive a Medication Guide unless the patient or caregiver requests it. A healthcare professional who determines that it is not in a patient’s best interest to receive a Medication Guide because of significant concerns about its effects may direct that it not be provided to that patient; however, the Medication Guide should be provided to any patient who requests the information.
Please refer to the following website in FDA for details:
http://www.fda.gov/Drugs/DrugSafety/ucm589213.htm
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 6 Mar 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/Thursday, May 17, 2018
Issued at HKT 15:00
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