The US Food and Drug Administration (FDA) is requiring a new class warning and other safety measures for all gadolinium-based contrast agents (GBCAs) for magnetic resonance imaging (MRI) concerning gadolinium remaining in patients’ bodies, including the brain, for months to years after receiving these drugs. Gadolinium retention has not been directly linked to adverse health effects in patients with normal kidney function, and FDA has concluded that the benefit of all approved GBCAs continues to outweigh any potential risks.
However, after additional review and consultation with the Medical Imaging Drugs Advisory Committee, FDA is requiring several actions to alert healthcare professionals and patients about gadolinium retention after an MRI using a GBCA, and actions that can help minimize problems. These include requiring a new patient Medication Guide, providing educational information that every patient will be asked to read before receiving a GBCA. FDA is also requiring manufacturers of GBCAs to conduct human and animal studies to further assess the safety of these contrast agents.
Healthcare professionals should consider the retention characteristics of each agent when choosing a GBCA for patients who may be at higher risk for gadolinium retention. These patients include those requiring multiple lifetime doses, pregnant women, children, and patients with inflammatory conditions. Minimize repeated GBCA imaging studies when possible, particularly closely spaced MRI studies. However, do not avoid or defer necessary GBCA MRI scans. Patients, parents, and caregivers should carefully read the new patient Medication Guide that will be given to them before receiving a GBCA.
To date, the only known adverse health effect related to gadolinium retention is a rare condition called nephrogenic systemic fibrosis (NSF) that occurs in a small subgroup of patients with pre-existing kidney failure. FDA has also received reports of adverse events involving multiple organ systems in patients with normal kidney function. A causal association between these adverse events and gadolinium retention could not be established.
FDA is continuing to assess the health effects of gadolinium retention in the body and will update the public when new information becomes available. FDA is requiring the following specific changes to the labeling of all GBCAs:
- A Warning and Precaution
- Changes related to gadolinium retention in the Adverse Reactions, Pregnancy, Clinical Pharmacology, and Patient Instructions sections
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 15 Dec 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.
Ends/Wednesday, Dec 20, 2017
Issued at HKT 16:00
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