Cleft Lip: What Drugs May Increase the Risks in Newborns?

Cleft lip is a birth defect characterized by a split or separation of the upper lip and can occur on one or both sides. While the exact cause is unknown, risks of having a baby with the physical deficiency may increase with the use of certain drugs during pregnancy. According to WebMD, oral cleft affects 700 babies each year and is the fourth most common birth defect in the U.S.

Topiramate and Oral Cleft

According to the American Dental Association (ADA), pregnant women who take the drug Topiramate increase the risks of oral cleft in babies. This conclusion stems from data the North American Antiepileptic Drug Pregnancy Registry collected, which the Food and Drug Administration (FDA) released in a safety alert. Risk extends to generic versions of Topiramate, as well.

Topiramate is a drug that treats epileptic seizures. The drug increases risks of cleft lip in newborns when its consumption occurs during the first trimester of pregnancy. In the article cited in the previous paragraph, the ADA explains that, "infants exposed to Topiramate as a single therapy experienced a 1.4 percent prevalence of oral clefts, compared with a prevalence of 0.38 percent - 0.55 percent in infants exposed to other antiepileptic drugs..."

HIV Drugs

Antiviral drugs taken by a pregnant woman may link to oral cleft in her baby, according to a recent American Dental Association news post. The study, published in the Cleft Palate-Craniofacial Journal, analyzes data in the FDA Adverse Events Reporting System (AERS) Database.

According to the study analysis, 26 cases of cleft lip and palate associate with antiretroviral therapies. The drugs included efavirenz, nelfinavir, nevirapine and lamivudine. The cases applied to both monotherapy and combination therapy situations for HIV-infected mothers.

The Conclusions

Cleft lip develops from a complex combination of genetic and environmental variables. The incidence of oral cleft in newborns may increase when pregnant women consume Topiramate and certain HIV drugs.

More research is necessary to solidify any direct links between the drugs and the facial defect that affects an infant's ability to eat, breathe and speak. To correct the defect, a baby usually goes through surgery at three or four months of age.

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