Cleft Lip and Palate Birth Defects May Be Linked to HIV Drugs: Study

The use of HIV drugs by pregnant women may increase the risk of their children being born with cleft palate and cleft lip birth defects, researchers warn. 

A new study that examines the potential link between antiretroviral HIV drugs and birth defects has been published by U.S. researchers in the Cleft Palate–Craniofacial Journal. Researchers found a number of incidents of cleft palate and cleft lip birth defects among the children of women who took the drugs while pregnant, but are unsure of whether there is an actual causal connection.

Antiretroviral drugs, including Epiver, EFV, Viracept, Ziagen and Retrovir, are often given to pregnant women who are HIV-positive in order to help prevent the spread of HIV to their children. The researchers said that the drugs appear to do their job, but there may be other side effects as well.

Mining data from the FDA’s MedWatch adverse events reporting program over a five year period, researchers found 26 incidents of children born with cleft palate or cleft lip born to mothers who took the drugs while pregnant. That is a higher rate of incidence than in the general population, but the findings were not enough to link the drugs to the defects, researchers cautioned.

Congenital malformations can have a variety of causes, including genetics and environmental issues. The scientists involved in the study have called for more studies to assess the safety of antiretroviral drugs for pregnant women.

Cleft palate and cleft lip occur when parts of the lip or palate fail to completely fuse together. The defect results in the child being born with defects as small as a notched lip to extreme as an open groove that goes from the roof of the mouth to the nose. Cleft palate and cleft lip can cause problems eating and talking and can increase the risk of ear infections, resulting in the need for corrective surgery.