Skip to main content
Toggle Menu of ADA WebSites
ADA Websites
Partnerships and Commissions
Toggle Search Area
Toggle Menu
e-mail Print Share

Study explores possible link between HIV drugs, birth defects

February 06, 2012

By Jean Williams, ADA News Staff


Antiviral drugs can reduce the risk of HIV transmission from mother to unborn child from 15 to 25 percent to less than 1 percent, but a new study explores whether a link exists between the drugs and cleft lip and palate.

The study published in the January issue of Cleft Palate-Craniofacial Journal evaluated reports of cleft lip and palate related to antiviral drugs. The reports were submitted between April 2004 and October 2009 to the U.S. Food and Drug Administration’s Adverse Events Reporting System—a publicly available pharmacovigilance database.

The authors’ analysis of the FDA adverse event database identified several antiretroviral therapies reported to have been associated with 26 cases of cleft lip and palate—including those used for monotherapy (efavirenz, lamivudine, nelfinavir and nevirapine) and for combination therapy (abacavir sulfate/lamivudine/zidovudine, lopinavir/ritonavir and lamivudine/zidovudine).

Cleft lip and palate are thought to have several causes involving genetic and environmental factors. Further research is necessary to determine if there is a link between antiviral medications and cleft lip and palate.

Access full text of the study—Anti-retroviral Prophylaxis and the Risk of Cleft Lip and Palate: Preliminary Signal Detection in the FDA AERS Database—at