- A higher dose of topiramate during
first trimester of pregnancy may increase a baby's risk of cleft lip or
- Pregnant women who took topiramate
had three times greater risk of having a baby with cleft lip or palate.
- Women with epilepsy on topiramate
had eight times greater risk of giving birth to a baby with cleft lip
or cleft palate.
Women who take high doses of
topiramate during the first three months of pregnancy have a higher risk of
giving birth to a baby with a cleft lip or palate, suggests new study published
, the medical journal of
the American Academy of Neurology. Topiramate is not a drug that is prescribed
during pregnancy; it is used to treat migraines, epilepsy and mood disorders.
However, the drug is commonly used and in case of unplanned pregnancies, this
becomes a problem.
is not recommended for pregnant women, unplanned pregnancies are common, so
it's important to fully examine any possible risk," said Sonia
Hernandez-Diaz, MD, DrPH, of the Harvard T.H. Chan School of Public Health in
Boston. "Our study found that when pregnant women took topiramate during
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."
The study, using
Medicaid data, identified about 1.4 million women who gave birth over a 10-year
period. Among them, women who filled a prescription for topiramate during their
first trimester were compared with women who did not fill a prescription for
any anti-seizure drug. Women who filled a prescription for topiramate were also
compared to women who filled a prescription for lamotrigine, another
‘Women with epilepsy and who took topiramate had the highest risk of giving birth to a baby with cleft lip or cleft palate.’
Total number of
pregnancies in each group:
- Pregnancies in the topiramate
- Pregnancies in the lamotrigine
- Pregnancies in the group not
taking anti-seizure drugs: 1.3 million
The research team
identified how many women from each of these groups gave birth to babies
diagnosed with cleft lip or cleft palate.
Number of babies born
with cleft lip or palate in each group:
- The group that did not take
anti-seizure drugs: 1,501 babies or a risk of 1.1 per 1,000 babies.
- The group that took topiramate:
4.1 per 1,000 babies
- The group that took lamotrigine:
1.5 per 1,000 babies
Moreover, women with
epilepsy on topiramate had an eight times greater risk of giving birth to a
baby with cleft lip or cleft palate compared to women who did not take any
anti-seizure drugs. Women who took topiramate for conditions other than
epilepsy had a 50% higher risk.
Women with epilepsy
required a higher dose of the drug than
women who took the same drug for other conditions. While the average daily dose
for women with epilepsy was 200 milligrams, the average dosage for women
without epilepsy was 100 milligrams. This further suggests that higher doses of
the drug were a major factor for the increased risk of giving birth to babies
with cleft lip or palate.
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," said
Hernandez-Diaz. "The best course may be to avoid prescribing high doses of
topiramate to women of childbearing age unless the benefits clearly outweigh