FDA News

FDA: HIV drug dolutegravir possibly linked to serious birth defects

The FDA issued a safety alert today warning patients and providers about a potential risk for neural tube birth defects in babies born to women with HIV who received dolutegravir during early pregnancy.

Preliminary findings from an ongoing observational study in Botswana suggest that women receiving dolutegravir at the time of becoming pregnant or early in the first trimester are at a higher risk for having an infant with neural tube birth defects impacting the brain, spine and spinal cord, according to the FDA. To date, there has been no evidence that starting dolutegravir later in pregnancy results in these birth defects. However, the FDA said participants enrolled in the observational study will continue to be monitored.

In light of this new information, the FDA recommends that physicians test women of childbearing age for pregnancy before prescribing treatment with dolutegravir. The agency also said that physicians should consider prescribing alternative antiretroviral drugs to this population.

“If the decision is made to use dolutegravir in women of childbearing age, health care professionals should reinforce the consistent use of effective birth control,” the FDA said.

According to the FDA, dolutegravir was approved in the United States in 2013. It is available under the brand name Tivicay (ViiV Healthcare) and as part of fixed-dose combinations under the brand names Juluca (dolutegravir/rilpivirine, ViiV Healthcare) and Triumeq (abacavir/dolutegravir/lamivudine; ViiV Healthcare).

For more information:

FDA. FDA Drug Safety Communication: FDA to evaluate potential risk of neural tube birth defects with HIV medicine dolutegravir (Juluca, Tivicay, Triumeq). https://www.fda.gov/drugs/drugsafety/ucm608112.htm. Accessed May 18, 2018.

The FDA issued a safety alert today warning patients and providers about a potential risk for neural tube birth defects in babies born to women with HIV who received dolutegravir during early pregnancy.

Preliminary findings from an ongoing observational study in Botswana suggest that women receiving dolutegravir at the time of becoming pregnant or early in the first trimester are at a higher risk for having an infant with neural tube birth defects impacting the brain, spine and spinal cord, according to the FDA. To date, there has been no evidence that starting dolutegravir later in pregnancy results in these birth defects. However, the FDA said participants enrolled in the observational study will continue to be monitored.

In light of this new information, the FDA recommends that physicians test women of childbearing age for pregnancy before prescribing treatment with dolutegravir. The agency also said that physicians should consider prescribing alternative antiretroviral drugs to this population.

“If the decision is made to use dolutegravir in women of childbearing age, health care professionals should reinforce the consistent use of effective birth control,” the FDA said.

According to the FDA, dolutegravir was approved in the United States in 2013. It is available under the brand name Tivicay (ViiV Healthcare) and as part of fixed-dose combinations under the brand names Juluca (dolutegravir/rilpivirine, ViiV Healthcare) and Triumeq (abacavir/dolutegravir/lamivudine; ViiV Healthcare).

For more information:

FDA. FDA Drug Safety Communication: FDA to evaluate potential risk of neural tube birth defects with HIV medicine dolutegravir (Juluca, Tivicay, Triumeq). https://www.fda.gov/drugs/drugsafety/ucm608112.htm. Accessed May 18, 2018.