New study suggests risk of birth defects in babies born to women on HIV medicine dolutegravir

European Medicines Agency, 18/05/2018

The European Medicines Agency (EMA) is evaluating preliminary results from a study which found 4 cases of birth defects such as spina bifida (malformed spinal cord) in babies born to mothers who became pregnant while taking dolutegravir. While EMA is assessing the new evidence it has issued the following precautionary advice:

  • Dolutegravir HIV medicines should not be prescribed to women seeking to become pregnant.
  • Women who can become pregnant should use effective contraception while taking dolutegravir medicines.

The study, which looked at babies born to 11,558 HIV-infected women in Botswana, showed that 0.9% of babies (4 of 426) whose mothers became pregnant while taking dolutegravir had a neural tube defect, compared with 0.1% of babies (14 of 11,173) whose mothers took other HIV medicines. Final results are expected in about a year.

Women who have been prescribed dolutegravir should not stop taking their medicine without first consulting their doctor.

EMA will update the recommendations as necessary when it concludes its assessment.

Pregnant women are at increased risk of domestic violence in all cultural groups

The Conversation, April 26, 2018 6.00pm AEST

Domestic violence occurs across all age groups and life stages. Rather than reducing during pregnancy, expecting a child is a key risk factor for domestic violence beginning or escalating.

Our research, published today in the journal BMJ Open, found that 4.3% of pregnant women due to give birth in Western Sydney disclosed domestic violence when asked about it by a midwife at her first hospital visit. The study examined more than 33,000 ethnically diverse women who gave birth between 2006 and 2016, and found that these disclosures spanned all cultural groups.