New safety information for women using dolutegravir, a medication used to treat HIV infection
- Starting date:
- June 7, 2018
- Type of communication:
- Information Update
- Source of recall:
- Health Canada
- Important Safety Information
- General Public, Healthcare Professionals
- Identification number:
- What you should do
- What industry professionals should do
- Report health or safety concerns
- Media enquiries
- Public enquiries
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.
What you should do
- 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.
What industry professionals should do
- Avoid prescribing dolutegravir to women who are trying to become pregnant, unless a suitable alternative treatment option is not available.
- Consider the risks and benefits of dolutegravir treatment when prescribing it to women of child-bearing potential.
- Advise women of child-bearing potential who are taking dolutegravir to avoid getting pregnant and to use effective contraception throughout the treatment.
- Inform women of the potential risk for neural tube defects when dolutegravir is used at the time of conception and, as a precautionary measure, during the first trimester of pregnancy.
- Perform pregnancy testing in women of child-bearing potential before initiating treatment.
- Switch to an alternative treatment, if available, when a pregnancy is confirmed in the first trimester while a woman is taking dolutegravir.
Report health or safety concerns
To report a side effect to a health product to Health Canada:
- Call toll-free at 1-866-234-2345.
- Visit Health Canada’s Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.