Other safety alerts
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| The United States: Gadolinium-based contrast agents for magnetic resonance imaging (MRI): Drug Safety Communication - FDA evaluating the risk of brain deposits with repeated use |
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FDA is investigating the risk of brain deposits following repeated use of gadolinium-based contrast agents (GBCAs) for magnetic resonance imaging (MRI). Recent publications in the medical literature have reported that deposits of GBCAs remain in the brains of some patients who undergo four or more contrast MRI scans, long after the last administration. It is unknown whether these gadolinium deposits are harmful or can lead to adverse health effects.
FDA, including its National Center for Toxicological Research (NCTR), will study this possible safety risk further. FDA is working with the research community and industry to understand the mechanism of gadolinium retention and to determine if there are any potential adverse health effects. Based on the need for additional information, at this time, FDA is not requiring manufacturers to make changes to the labels of GBCA products.
After being administered, GBCAs are mostly eliminated from the body through the kidneys. However, trace amounts of gadolinium may stay in the body long-term. Recent studies conducted in people and animals have confirmed that gadolinium can remain in the brain, even in individuals with normal kidney function. Available information does not identify any adverse health effects.
To reduce the potential for gadolinium accumulation, health care professionals should consider limiting GBCA use to clinical circumstances in which the additional information provided by the contrast is necessary. Health care professionals are also urged to reassess the necessity of repetitive GBCA MRIs in established treatment protocols.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/MedWatch/../ucm456012.htm
In Hong Kong, there are nine registered pharmaceutical products which are GBCAs, and are prescription-only medicines, including Magnevist Inj (HK-32608), Omniscan Inj 0.5mmol/ml (HK-43493), Gadovist Inj 1mmol/ml (HK-51750) and Gadovist Inj 1mmol/ml (Pre-filled Syringe) (HK-57330), Primovist Pre-filled Syringe Inj 0.25mmol/ml (HK-54116), Dotarem Inj 377mg/ml (Vial) (HK-41578) and Dotarem Prefilled Syringes, 377mg/ml (HK-41579), MultiHance Inj 334mg (China) (HK-55495) and MultiHance Inj 334mg (HK-57789). So far, the Department of Health (DH) has received 2 cases of adverse drug reaction (ADR) related to Omniscan, and they were not related to brain deposits. The DH has not received any cases of ADR related to the other registered GBCA products. In view of the US FDA’s announcement that it is unknown whether the gadolinium deposits are harmful or can lead to adverse health effects and additional information is needed to determine whether changes to the labels of GBCA products are required, the DH will remain vigilant on the conclusion by the US FDA, and safety updates by other overseas drug regulatory authorities regarding GBCA products for consideration of any action deemed necessary.
Ends/ Tuesday, July 28, 2015
Issued at HKT 14:00
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