Seizure, migraine medications linked to birth defects cleft lip, spina bifida and more
The American Academy of Neurology released news of a large study that has confirmed women who take either valproic acid or topiramate in the early months of pregnancy may have an increased risk of giving birth to a baby with birth defects. The study is published in the June 12, 2019, online issue of Neurology.
Epilepsy drugs are not only prescribed to prevent seizures, they are increasingly prescribed for migraine, pain and psychiatric disorders such as bipolar disorder. “Because these drugs are being prescribed more widely, and because unplanned pregnancies are not uncommon, we wanted to examine their safety with a much larger study,” said study author Rosemary Dray-Spira, MD, PhD, of the French National Agency for Medicines and Health Products Safety in Saint-Denis, France, in a statement.
For the study, researchers used French national healthcare databases containing data on nearly all pregnancies in the country. They identified more than 1.8 million pregnancies lasting five months or longer that ended in live births between January 2011 and March 2015. Among those pregnancies, researchers then identified women who were prescribed one of 10 seizure drugs from one month before pregnancy to within the first two months of the pregnancy. If they were taking more than one seizure drug, they were not included in the study. Researchers also examined the records of children born to these women, looking for 23 birth defects up to one or two years after birth, depending on the type of birth defect.
Accounting for factors that could affect the risk of birth defects, such as age, folic acid supplementation and pre-gestational diabetes, researchers found that the women prescribed valproic acid had a 19 times greater risk of having a baby with spina bifida when compared to the women who did not take an epilepsy drug. Among the 913 women prescribed valproic acid, six babies had spina bifida, or 0.66 percent, compared to 616 babies of the 1,875,733 women who did not take an epilepsy drug, or 0.03 percent. Valproic acid also increased the risk of seven other birth defects including cleft palate and four types of heart defects.
In addition, researchers found that women who were prescribed topiramate had a seven times greater risk of having a baby with cleft lip with or without cleft palate. Among the 517 women prescribed topiramate, three babies had cleft lip, or 0.60 percent compared to 1,637 babies of the more than 1.8 million women who did not take an epilepsy drug, or 0.09 percent.
Researchers found no greater risk of birth defects associated with lamotrigine, levetiracetam, carbamazepine, oxcarbazepine and gabapentin.
“Our study not only confirmed what smaller studies have found, it also looked at a broader range of birth defects, contributing to a better and more complete understanding of the use of epilepsy drugs during pregnancy,” said Dray-Spira. “These results may help guide doctors as they make prescribing decisions and look for alternative treatments for their patients who are of childbearing age.”
One limitation of the study was that the determination of epilepsy drug use was based on prescription records. Those records did not show whether a person actually took the medication.
