Cleft lip often forms early in the pregnancy, before many women are aware that they are even pregnant. This is why being careful before pregnancy is so important. According to Jennifer Shepherd, a pharmacist in the FDA’s Division of Drug Information, topiramate has been linked to developing cleft lip in some infants. Women who could become pregnant are being warned about this possible side effect of the medication.
“The benefits and the risks of topiramate should be carefully weighed when prescribing this drug to women of childbearing age, particularly for conditions not usually associated with permanent injury or death,” Shepherd said. “Alternative medications that have a lower risk of oral clefts and other adverse birth outcomes should be considered for these patients.
Topiramate is used to treat patients with epilepsy and to prevent migraine headaches. Between 2007 through 2010, there were more than 32 million prescriptions of the drug given out. Data from the North American Antiepileptic Drug, or NAAED, found that women who took this medication early in pregnancy had an increased risk of having a child with a cleft lip. The average occurrence of cleft lip is only 0.07 percent. However, women taking topiramate had an occurrence at 1.4 percent. This large increase is why doctors should be worried.
The FDA is reclassifying topiramate as a pregnancy category D drug, meaning there are known fetal risks if taken during pregnancy. However, there is still a benefit from taking the medication for sufferers of epilepsy. Women who may become pregnant should talk to their doctors about their medication to see if an alternative will be as effective. – Summer, staff writer
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