An FDA review to date has not identified adverse health effects from gadolinium retained in the brain after the use of gadolinium-based contrast agents (GBCAs) for magnetic resonance imaging (MRI). All GBCAs may be associated with some gadolinium retention in the brain and other body tissues. However, because FDA identified no evidence to date that gadolinium retention in the brain from any of the GBCAs, including GBCAs associated with higher retention of gadolinium, is harmful, restricting GBCA use is not warranted at this time. FDA will continue to assess the safety of GBCAs and plan to have a public meeting to discuss this issue in the future.
FDA evaluated scientific publications and adverse event reports submitted to FDA. Some human and animal studies looked at GBCA use over periods longer than a year. These publications and reports show that gadolinium is retained in organs such as the brain, bones, and skin. The publications show that linear GBCAs retain more gadolinium in the brain than macrocyclic GBCAs. However, the review did not identify adverse health effects related to this brain retention.
FDA continues to assess the safety of GBCAs. FDA’s National Center for Toxicological Research is conducting a study on brain retention of GBCAs in rats. Other research is also being conducted about how gadolinium is retained in the body. FDA will update the public when new information becomes available and we plan to have a public meeting to discuss this issue in the future.
Gadolinium-Based Contrast Agents are intravenous drugs used in diagnostic imaging procedures to enhance the quality of magnetic resonance imaging or magnetic resonance angiography.
FDA recommendations for health care professionals and patients remain unchanged from July 2015 when FDA informed the public that FDA was investigating this potential risk with GBCAs. As is appropriate when considering the use of any medical imaging agent, health care professionals should limit GBCA use to circumstances in which additional information provided by the contrast agent is necessary, and assess the necessity of repetitive MRIs with GBCAs. Patients, parents, and caregivers should talk to their health care professionals if they have any questions or concerns about the use of GBCAs with MRIs. Retention of gadolinium affects only GBCAs, and does not apply to other types of scanning agents used for other imaging procedures, such as those that are iodine-based or radioisotopes.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/MedWatch/../ucm559709.htm
In Hong Kong, there are eight 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 July 2015, with the latest update posted on 11 March 2017. So far, the Department of Health (DH) has received seven cases of adverse drug reaction (ADR) in connection with GBCAs: two cases on Omniscan, three cases on Dotarem, and two cases on Gadovist. These reported ADR cases were not related to brain deposits. DH will remain vigilant on the safety updates from other overseas drug regulatory authorities on the adverse health effects of GBCAs.
Ends/ Tuesday, May 23, 2017
Issued at HKT 12:45
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