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Study Explores Association of Antiretroviral Drugs With Birth Defects

February 13, 2012

HIV-positive mothers have been able to guard against transmitting the virus to their babies by taking antiretroviral drugs during pregnancy. A new study explores possible links between antiretroviral prophylaxis and the birth defect cleft lip and palate.

The study, published in the January issue of Cleft Palate-Craniofacial Journal, analyzed five years of data from the Food and Drug Administration's (FDA's) Adverse Events Reporting System. This publicly available database offers a resource for pharmaco-vigilance. 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 15-25% to less than 1%. While this success has made the use of antiretroviral medications a standard of care, none of these drugs has been classified as a category A (safe) drug for pregnancy.

In this study, 26 events of cleft lip and palate were found in relation to seven antiviral drugs, including Sustiva (efavirenz), Epivir (lamivudine), Viracept (nelfinavir), and the combination drug Trizivir (abacavir/lamivudine/zidovudine). Although these drugs showed significantly high reporting odds ratios, this does not establish causality, but serves as an alert to a possible association.

Cleft lip and palate is a congenital malformation that is believed to have several causes. Genetic and environmental factors have been shown to play a role. Poor nutrition, including an excess of vitamin A and a deficiency of other vitamins and minerals, can contribute to its development as well. The study concluded that further research is needed to determine if there is a link between antiretroviral medications and cleft lip and palate.

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