Tuesday, February 07, 2012

Antiretroviral Drugs Guard Against HIV but May Lead to Birth Defects?

A study in the January issue ofCleft Palate-Craniofacial Journal analyzed five years of data from the U.S. FDA's Adverse Events Reporting System (AERS). This publicly available database offers a resource for pharmacovigilance. By using "reporting odds ratios," a potential association may be found between drugs and birth defects.

With the use of antiretroviral drug therapy, the risk of HIV transmission from mother to child has been reduced from 15 to 25 percent to less than 1 percent. While this success has made the use of antiretroviral medications a standard of care, none of these drugs has been classified as safe -- category A -- for pregnancy. The potential risks to offspring must continue to be explored.
In this study, 26 events of cleft lip and palate were found in relation to seven antiviral drugs, including efavirenz, lamivudine, nelfinavir, and the combination of abacavir/sulfate/laminudine/zidovudine. Although these drugs showed significantly high reporting odds ratios, this does not establish causality, but serves as an alert to a possible association.