New safety information for women using dolutegravir, a medication used to treat HIV infection

June 7, 2018 For immediate release OTTAWA – 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 Department 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.

Product safety

Serious cases of neural tube defects have been reported in the Botswana study in about 1% of babies born to women taking dolutegravir when they conceived. Patients using dolutegravir should not stop taking it without first talking to their health care professional, as this can cause the HIV infection to worsen. Women planning to become pregnant and taking dolutegravir should discuss treatment options with their doctor before becoming pregnant. Women taking dolutegravir should avoid getting pregnant and should use effective contraception. Women who become pregnant while taking dolutegravir should consult with their health care professional right away.