OTTAWA, June 7, 2018 /CNW/ - Health Canada is informing the public of the potential risk of serious birth defects in babiesborn 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
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.
Information for healthcare professionals:
Information for patients:
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SOURCE Health Canada
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