ADR that result in revision of patient information
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| Canada : New safety information for women using dolutegravir, a medication used to treat HIV infection |
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Health Canada is informing the public of the potential risk of serious birth defects in babies born to women treated with dolutegravir. Dolutegravir is a medication used to treat HIV infection.
Dolutegravir is sold under the brand name Tivicay, and as a fixed dose combination tablet with other HIV medicines under the brand names Juluca and Triumeq.
Preliminary results (4 cases) from an ongoing study in Botswana suggest a possible increased risk of neural tube defects in babies born to women who became pregnant while taking dolutegravir. Neural tube defects are defects that occur when the spinal cord, brain, and related structures do not form properly.
While Health Canada is not aware of any Canadian cases of infants born with birth defects to women using dolutegravir, the authority and the manufacturer will continue to monitor the results of the Botswana study and take appropriate action, if necessary. If there is any new safety information, Health Canada will update Canadians, including health professionals, as required.
Given the potential risk of serious birth defects, Health Canada advises patients to discuss any questions or concerns about the use of dolutegravir with their healthcare professional.
Please refer to the following website in Health Canada for details:
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../67010a-eng.php
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.
Related news was previously issued by the US Food and Drug Administration (FDA), European Medicines Agency (EMA), Therapeutic Goods Administration (TGA) and Health Sciences Authority (HSA); and was posted on the Drug Office website on 19 May 2018, 1 June 2018 and 5 June 2018. Letters to inform local healthcare professionals of the above safety information were issued by the DH on 21 May 2018. The DH will keep vigilant on any further update from the FDA, EMA, TGA, HSA, Health Canada and other health authorities for consideration of any action deemed necessary.
Ends/ Friday , June 8, 2018
Issued at HKT 17:45
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