US and European drug agencies had already issued warnings about dolutegravir, or DTG, in May this year. The drug is an antiretroviral that has been used to prevent infection after possible exposure to HIV.
DTG is manufactured by British pharmaceutical firm GlaxoSmithKline. The company responded to the concerns in May by saying it was working with healthcare authorities to better understand the potential risk. Early results from a study involving HIV-positive women in Botswana showed that about 1% of babies born to those who were using DTG when they became pregnant or shortly after, developed a birth defect affecting the spinal cord or brain.
Based on those findings, countries that already prescribe the drug have advised health workers not to give it to women of childbearing age. Women who are already using DTG are advised to use contraception or talk to their health providers about alternatives if they are considering getting pregnant.
The drug was approved by the US Food and Drug Administration in 2013 and is currently one of the key therapies for people living with HIV