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Risk of Oral Clefts with Topiramate May Be Dose-Dependent

Risk of Oral Clefts with Topiramate May Be Dose-Dependent

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Action Points

  • The risk of oral clefts (cleft lip or palate) at birth was almost threefold higher among infants born to women exposed to topiramate compared with an unexposed group, with greater risk among women taking higher higher doses of the drug, in a study of women enrolled in Medicaid.
  • Note that unplanned pregnancies are common, occurring at a rate of about 50%, and topiramate is not recommended for pregnant women.

Higher doses of the anti-seizure drug topiramate taken during the first trimester of pregnancy were associated with a significantly increased risk for cleft lip or palate in the newborn, researchers found.

In an analysis of nearly 1.4 million women enrolled in Medicaid from 2000 to 2010, the risk of oral clefts at birth was almost threefold higher among infants born to women exposed to topiramate compared with an unexposed group (RR 2.90, 95% CI 1.56 to 5.40), Sonia Hernandez-Diaz, MD, of the Harvard T.H. Chan School of Public Health in Boston, and colleagues reported online in Neurology.

That risk was greater among women taking higher higher doses of the drug, they reported.

“While topiramate is not recommended for pregnant women, unplanned pregnancies are common [occurring at a rate of about 50%], so it’s important to fully examine any possible risk,” Hernandez-Diaz told MedPage Today. “Our study found that when a pregnant women took topiramate during the first trimester, baby’s risk of cleft lip or palate was three times greater than if mom was not taking the drug. The risk was higher when the mother took high doses of the drug than when she took lower doses.”

For their study, Hernandez-Diaz and colleagues looked at data from the 2000-2010 Medicaid Analytic eXtract on 1,360,101 pregnant women with a live-born infant enrolled in Medicaid from three months before conception through one month after delivery. A total of 2,425 infants were born to women exposed to topiramate during that time, and about 2,800 women had filled prescriptions for another anti-seizure drug, lamotrigine, which has been shown to be safer during pregnancy. Previous research has linked maternal use of topiramate early in pregnancy with a two- to five-fold increased risk of oral clefts in the infant, and also with low birth weight.

The researchers found that the risk of oral clefts at birth was 4.1 per 1,000 in the infants exposed to topiramate compared with 1.1 per 1,000 in those unexposed.

When looking at women taking topiramate specifically for epilepsy — indicating higher doses of the drug — the risk was even higher (RR 8.30, 95% CI 2.65 to 26.07). But among women taking the drug for bipolar — suggesting lower doses — the risk was not significant (RR 1.45, 95% CI 0.54 to 3.86). The median daily dose for the first prescription filled during the first trimester was 200 mg for women with epilepsy and 100 mg for women without epilepsy.

Indeed, they found that for topiramate monotherapy, risk of oral clefts was higher with higher doses: RR 5.16, 95% CI 1.94 to 13.73 for doses above 100 mg compared with a non-significant RR 1.64, 95% CI 0.53 to 5.07 for doses of 100 mg and below.

The researchers noted that results were similar when lamotrigine was used as the comparator.

“Questions remain as to whether the lower doses used for non-epilepsy indications also confer risk,” they wrote, adding that there’s particular concern for the weight-loss drug Qsymia, a combination of phentermine and topiramate, albeit at lower doses. “More low-dose exposures may result from future (unplanned) pregnancies,” they wrote.

Gregory Krauss, MD, of Johns Hopkins in Baltimore, who was not involved in the study, noted that while a number of studies have shown an increased risk of oral clefts with topiramate, “this study shows that it is dose-dependent.”

“When used for epilepsy at doses of 100 to 600 mg, there is substantial increased risk, whereas when used for headache and mood disorders at lower doses of 50 to 100 mg – as it has been in literally millions of people – the risk is minimal, and given the confidence intervals, didn’t really reach significance,” Krauss said.

The study was limited by the potential for selection bias and misclassification, but Hernandez-Dias said the results “suggest that women with epilepsy on topiramate have the highest relative risk of giving birth to a baby with cleft lip or cleft palate, likely due to the higher doses of topiramate when used for controlling seizures.”

“The best course may be to avoid prescribing high doses of topiramate to women of childbearing age unless the benefits clearly outweigh the risks,” she said.

This work was supported by the National Institute of Mental Health.

Hernandez-Diaz and several co-authors reported financial relationships with industry.


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