PRAC Again Warns Against Dolutegravir Use During Pregnancy

Troy Brown, RN

Disclosures

October 05, 2018

The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has confirmed its earlier precautionary advice regarding the use of dolutegravir (multiple brands) by women who are or who could become pregnant.

On May 18, 2018, the EMA and the US Food and Drug Administration warned that women should undergo pregnancy testing before beginning treatment with dolutegravir; that women who can become pregnant should use effective contraception while taking the drug; and that women should not take it during the first trimester of pregnancy unless no alternative is available.

The precautionary advice comes after release of preliminary study results regarding infants born to 11,558 women with HIV in Botswana. The study found four cases of neural tube defects — birth defects of the brain, spine, and spinal cord — among 426 infants (0.9%) born of HIV-infected women in Botswana who took dolutegravir during pregnancy, compared with 14 infants (0.1%) born to 11,173 women who took other HIV medications. The study is ongoing; the PRAC will conduct additional assessment and issue final recommendations when the study's final results become available in 2019.

The PRAC advises that women who have been prescribed dolutegravir should not discontinue the medication before consulting with their physician.

As a precaution, the PRAC is advising healthcare professionals in the EU of the following:

  • Do not prescribe dolutegravir to women who have the potential to bear children and who are trying to become pregnant.

  • Exclude pregnancy in women who have the potential to bear children before starting dolutegravir.

  • Advise women who have the potential to bear children and who are taking dolutegravir to use effective contraception throughout treatment.

  • If pregnancy is confirmed in the first trimester while a woman is taking dolutegravir, switch to an alternative treatment unless there is no suitable alternative.

Healthcare professionals in the EU will be sent a letter concerning these recommendations.

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