Other safety alerts
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| The United States: FDA Drug Safety Communication: FDA to evaluate potential risk of neural tube birth defects with HIV medicine dolutegravir (Juluca, Tivicay, Triumeq) |
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The U.S. Food and Drug Administration (FDA) is alerting the public that serious cases of neural tube birth defects involving the brain, spine, and spinal cord have been reported in babies born to women treated with dolutegravir used to treat human immunodeficiency virus (HIV). Preliminary results from an ongoing observational study in Botswana found that women who received dolutegravir at the time of becoming pregnant or early in the first trimester appear to be at higher risk for these defects.
Neural tube defects are birth defects that can occur early in pregnancy when the spinal cord, brain, and related structures do not form properly. To date, in this observational study there are no reported cases of babies born with neural tube defects to women starting dolutegravir later in pregnancy. They are investigating this new safety issue and will update the public when they have more information.
Dolutegravir is an FDA-approved antiretroviral medicine used in combination with other antiretroviral medicines to treat HIV, the virus that can cause acquired immunodeficiency syndrome (AIDS). Dolutegravir works by blocking integrase, an HIV enzyme, to prevent the virus from multiplying and can reduce the amount of HIV in the body. Stopping dolutegravir without first talking to a prescriber can cause the HIV infection to become worse. Approved in 2013, dolutegravir has been on the market for 5 years, and is available as a single ingredient product under the brand name Tivicay and as a fixed dose combination tablet with other HIV medicines under the brand names Juluca and Triumeq.
Ongoing monitoring will continue as part of the observational study in Botswana. Additional birth outcomes are projected from pregnant women who were exposed to dolutegravir at the time of becoming pregnant. They will conduct a comprehensive review of the results and any other data that becomes available. They will update the public with any new information.
Please refer to the following website in US FDA for details:http://www.fda.gov/Drugs/DrugSafety/ucm608112.htm
In Hong Kong, there are 2 registered pharmaceutical products containing dolutegravir, namely Tivicay Tablets 50mg (HK-63516) and Triumeq Tablets (HK-64012). Both products are registered by Glaxosmithkline Limited, and are prescription-only medicines. So far, the Department of Health (DH) has received 3 cases of adverse drug reaction related to dolutegravir, but these cases were not related to birth defects. In view of US FDA’s announcement, letters to inform local healthcare professionals of the above safety information will be issued. The DH will keep vigilant on any further update from the US FDA and other health authorities.
Ends/ Saturday, May 19, 2018
Issued at HKT 12:00
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