FDA Issues Safety Alert for Drug Linked to Potential Birth Defects – APhA submits compounding comments to FDA. – (866) 348-2889.
Serious cases of neural tube birth defects, including spina bifida, have been reported in babies born to women with HIV being treated with dolutegravir. In response, safety alerts have been issued by the FDA, and the European Medicines Agency (EMA).
According to an ongoing observational study in Botswana, women who received dolutegravir at the time of becoming pregnant or early in the first trimester appear to be at higher risk for birth defects involving the brain, spine, and spinal cord.1-2 The study has looked at babies born to 11,558 women with HIV in Botswana. The study’s current data suggest that 0.9% of these 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 were taking other HIV medications.2
There are no reported cases of babies born with neural tube defects to women that started dolutegravir later in the pregnancy cycle, but the FDA is continuing to investigate the safety issue.1 Final results of the Botswana study are expected in about a year.2