RESEARCH TRIANGLE PARK – The European Medicines Agency is warning that an HIV drug sold by ViiV Healthcare may pose a risk of birth defects.
Reuters reported Friday that the drug known as dolutegravir, is “a so-called integrase inhibitor found in the branded medicines Tivicay and Triumeq, which are sold by GSK’s majority-owned ViiV Healthcare unit.”
ViiV has a number of researchers based in the Triangle.
The EMA said the drug should not be prescribed to women seeking to become pregnant, Reuters noted.
Reuters added that GSK “was notifying doctors of the issue and working with healthcare authorities to better understand the potential risk.”
“There is no known mechanism linking dolutegravir with these types of birth defects and there are no relevant findings in pre-clinical studies,” GSK said in a statement published by Reuters.
“Animal models are generally predictive of drug-induced birth defects and it is very unusual to see an effect in humans if no evidence is observed in animal models.
