Antiretroviral Drugs May Cause Cleft Lip and Palate
Antiretroviral Drugs May Cause Cleft Lip and Palate Women who are pregnant and infected with human immunodeficiency virus (HIV) may protect their unborn children from the disease by taking antiretroviral drugs. But, according to a study published in the January
Antiretroviral Drugs May Cause Cleft Lip and Palate
Women who are pregnant and infected with human immunodeficiency virus (HIV) may protect their unborn children from the disease by taking antiretroviral drugs. But, according to a study published in the January issue of Cleft Palate-Craniofacial Journal, these drugs many also cause birth defects, including cleft lip and palate. The study, led by Vassiliki M. Cartsos, DMD, MSD; Pinelopi Kleio Palaska, DMD; and Anthanasios I. Zavaras, DMD, MS, DrMSc, analyzed 5 years of public data to reach the conclusion that a link exists between antiretroviral drugs and clefting.
The reported link between antiretroviral prophylaxis and cleft lip and palate was reached through analysis of data dated April 2004 to October 2009, available from the United States Food and Drug Administration’s (FDA) Adverse Events Reporting System (AERS)—a public database that includes spontaneous adverse effects reports submitted voluntarily from health care professionals. In fact, the FDA analyzes AERS data to issue warnings, mandate label changes, and sometimes demand products be pulled from the market.
Antiretroviral drug therapy has been clinically shown to reduce the risk of HIV transmission from mother to fetus from 15% to 25% to less than 1%. This clear advantage is not without risk, however. Authors, in their data analysis, found 26 instances of cleft lip and palate related to seven antiretroviral drugs: efavirenz, lamivudine, nelfinavir, and a combination of abacavir/sulfate/zidovudine. (Important to note is that the study included only reported events of cleft lip and palate; not cleft lip or cleft palate alone). While that number is relatively small, a possible association between antiretroviral drugs and clefting cannot be ignored.
Additionally, because genetics and environment—as well as nutrition—can contribute to clefting, the authors report that further research is needed to determine whether the association between antiretroviral drugs and birth defects is valid.
