Reactions 1704, p1 - 2 Jun 2018
FDA, EMA reviews of dolutegravir
underway after birth defects
Reviews are underway in the US and EU into the
safety of the HIV medicine dolutegravir following
serious cases of neural tube defects, according to the US
FDA and EMA.
In the US, dolutegravir was granted marketing
approval in 2013 and it is available as a single ingredient
product (Tivicay) as well as a fixed-dose combination
tablet with other HIV medicines (dolutegravir/rilpivirine
[Juluca]; abacavir/dolutegravir/lamivudine [Triumeq]).
The FDA has stated that "preliminary results from an
ongoing observational study in Botswana found 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". However, the FDA
added that there have been no reported cases of babies
born with neural tube defects whose mothers initiated
dolutegravir later in their pregnancy.
The EMA is also evaluating preliminary data from this
Botswana study involving >11 500 HIV-infected
It was demonstrated that 0.9% of babies
experienced a neural tube defect whose mothers
became pregnant while receiving dolutegravir, versus
0.1% of babies whose mothers took other HIV
medicines. Final results from this study are expected in
approximately 1 year.
In the EU, dolutegravir has been authorised since
2014 (as Tivicay and Triumeq). Juluca has received a
positive opinion from the CHMP
and is awaiting a
decision from the European Commission.
In the meantime while the FDA and EMA are
conducting their respective reviews, healthcare
professionals and/or patients are advised to follow this
Dolutegravir-containing HIV medicines should not
be prescribed to women intending to become
Women who are capable to becoming pregnant
should use effective contraception while taking
Before starting dolutegravir therapy, women should
take a pregnancy test to determine if they are already
Women prescribed dolutegravir should not stop
taking this medicine without first consulting their
If pregnancy is confirmed in the first trimester while
a woman is receiving dolutegravir, their healthcare
professional should switch them to an alternative
treatment (unless no suitable treatment is available).
* CHMP = Committee for Medicinal Products for Human Use
1. US Food and Drug Administration. FDA Drug Safety Communication: FDA to
evaluate potential risk of neural tube birth defects with HIV medicine
dolutegravir (Juluca, Tivicay, Triumeq). Internet Document : 18 May 2018.
Available from: URL: https://www.fda.gov/Drugs/DrugSafety/ucm608112.htm.
2. European Medicines Agency. New study suggests risk of birth defects in babies
born to women on HIV medicine dolutegravir. Internet Document : 18 May
2018. Available from: URL: http://www.ema.europa.eu/ema/
Reactions 2 Jun 2018 No. 17040114-9954/18/1704-0001/$14.95 Adis © 2018 Springer International Publishing AG. All rights reserved