Safety warning for dolutegravir issued over potential risk of neural tube birth defects

Both the US FDA and the European Medicines Agency (EMA) are investigating reports of neural tube defects in babies born to women on GlaxoSmithKline’s (GSK; Brentford, UK) antiretroviral drug dolutegravir.

Dolutegravir, an integrase inhibitor approved in the US in 2013 and in Europe in 2014, is used in combination with other drugs to treat HIV. It is available as a single drug under the brand name Tivicay®, and as a fixed-dose combination tablet in Juluca® and Triumeq®, all marketed by GSK via its majority-owned ViiV Healthcare unit.

The new concerns surrounding the drug stem from an ongoing observational study in Botswana, which has assessed babies born to 11,558 HIV-infected women. The study reports that 0.9% of babies (4 of 426) whose mother became pregnant while taking dolutegravir had a neural tube defect, compared with 0.1% of babies (14 of 11,173) in mothers taking other HIV medicines.

The FDA stated that women who received dolutegravir at the time of becoming pregnant or early in the first trimester appear to be at higher risk for these defects.

Although final results are expected in approximately a year and the role of dolutegravir in the four birth defects is yet to be established, both agencies have issued caution. The EMA has recommended that this drug shouldn’t be prescribed to women seeking to become pregnant, and women on dolutegravir who can become pregnant should use contraception. Both The FDA and EMA both state that women should not stop taking dolutegravir without first consulting their doctor; however, they are advising healthcare professionals to inform women about the potential risk of neural tube defects.

In a statement GSK commented: “There is no known mechanism linking dolutegravir with these types of birth defects and there are no relevant findings in pre-clinical studies.”

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