Epilepsy drugs linked to higher risk of birth defects

Two medicines used to control epileptic seizures — as well as prescribed to patients with migraine, pain as well as bipolar disorder — are associated with an increased risk of birth defects, fresh research indicates.

Women who took valproic acid or topiramate from the early months of their pregnancies had a higher-than-usual chance of having babies with birth defects, including spina bifida as well as cleft lip, according to a study published Wednesday in Neurology.
Anti-epileptic drugs, particularly the newest ones, are increasingly prescribed for medical conditions unrelated to epilepsy. Prevalence of epilepsy medicine use for any reason during pregnancy is actually reported as 21.9 per 1,000 expectant women from the United States, 6.7 per 1,000 in France as well as 4.3 per 1,000 from the Netherlands, according to a 2018 study cited by the researchers.

For the study, researchers used data by the French national health care system to identify pregnancies that will resulted in live births between January 2011 as well as March 2015. Among the 1,886,825 pregnancies, the researchers looked for the mothers’ use of 10 anti-seizure drugs before as well as after conception as well as searched for 23 birth defects from the children born to these women.

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A total 8,794 women had been prescribed 1 anti-epileptic drug, the researchers found.

Women prescribed valproic acid (10.4% of the group of pregnant women prescribed anti-epileptic medication) had a 19 times greater risk of having a baby with spina bifida compared with women who did not take an epilepsy drug. Among the 913 women prescribed valproic acid, six babies (0.66%) had spina bifida, compared with 616 babies (0.03%) born to women not taking an epilepsy drug. Valproic acid also increased the risk of seven various other birth defects, including cleft palate as well as four types of heart defects.

Women prescribed topiramate (5.9%) had a seven times greater risk of having a baby with cleft lip (with or without cleft palate), the study indicated. Among the 517 women prescribed topiramate, three babies (0.60%) had cleft lip, compared with 1,637 babies (0.09%) born to women not taking an epilepsy drug.

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No elevated risks for birth defects were associated with lamotrigine, levetiracetam, carbamazepine, oxcarbazepine as well as gabapentin.

The researchers caught weak signals linking clonazepam to a higher risk of microcephaly (a little head circumference that will is actually associated with lower IQ), while individually, phenobarbital as well as pregabalin were linked to higher risks of different types of heart defects. These associations were based on very few babies as well as so cannot be considered statistically significant, they said.

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Dr. David Ficker, chairman-elect of the professional advisory board of the Epilepsy Foundation, said the fresh study “confirms various other large-scale studies where similar findings were found. the idea reinforces the risks associated with these particular two medications.”

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“We’ve been concerned about valproic acid for many years,” said Ficker, who was not involved from the fresh research. He recalled a study by the early 2000s that will found an association between the drug as well as a higher risk of major congenital malformations. After these revelations, “use of valproic acid in women of childbearing age decreased considerably,” he said.

There are different levels of care for patients with epilepsy, with some treated by their primary care providers, others treated by neurologists as well as still others receiving treatment by epilepsy specialists — neurologists with special training from the disease.

“Definitely from the epilepsy physician community, we are well aware of the risks of valproic acid during pregnancy. I think even from the neurology community,” said Ficker, who is actually also a professor of neurology at University of Cincinnati Gardner Neuroscience Institute. However, the primary care community may not recognize potential safety risks, he said.

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“I also know that will there are some women with difficult-to-control epilepsy that will valproic acid may be the only medication that will might be effective for them. All these different medicines have different ways of working from the brain, as well as they’re not necessarily completely interchangeable.”

“Fortunately, for many women, there are alternative medications that will can be used that will have a better safety profile during pregnancy,” he said.

Guidelines by the Academy of Neurology recommend that will doctors prescribe a medicine that will poses no risk to a developing fetus as well as, if possible, only one seizure medicine at a time: “If someone is actually on more than one seizure medicine, the risk of birth defects increases,” Ficker said.
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Still, the idea is actually important to control seizures because they pose dangers — such as falling, miscarriage, reduced oxygen to the fetus as well as fetal distress — to a developing baby as well, he said.

Ultimately, Ficker cautions women with epilepsy who are of childbearing age or pregnant, “do not stop your medication without speaking to your treating physician.”

Interactions with birth control

American Epilepsy Society President Dr. Page Pennell agreed that will the study’s findings are not fresh, as most of these associations between anti-epilepsy drug use during pregnancy as well as birth defects were known based on “many studies” of populations in North America, Australia as well as various other countries in Europe.

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Yet previous studies have found evidence of additional negative associations, wrote Pennell, who was not involved from the fresh research, in an email: “Most notable, valproic acid use during pregnancy has been associated with higher risk for lower IQ, autism as well as autism spectrum disorder, as well as need for special education from the children who were exposed during pregnancy. Topiramate has also been associated with increased risk for low birth weight.”

Though the evidence is actually not substantial, she also highlighted the study’s “relatively fresh findings” of an association with clonazepam use as well as microcephaly as well as pregabalin use as well as a heart defect. Of the total women prescribed anti-epileptic drugs, 11.1% had received a script for clonazepam as well as 19.0% for pregabalin, the study found.

The fresh research also suggests that will neurologists are proactive about ensuring patients of childbearing age take supplemental folic acid, which “has been associated with lowering the risk for neurodevelopmental disorders including autism in children of women with epilepsy,” Pennell said.

Like Ficker, she recommends counseling for young women prescribed anti-epileptic drugs, since “over 50% of the pregnancies are unplanned from the US,” as well as women taking anti-epileptic drugs “still have a high unplanned pregnancy rate,” despite the known risks.

Not all of these pregnancies are due to a lack of forethought, though. Carbamazepine, she explained, as well as some of the various other drugs for controlling seizures may interact with birth control as well as “can increase the rate of unplanned pregnancies.”

At dosages greater than 0 milligrams a day, topiramate may also diminish the effectiveness of some hormonal contraceptives.

Pennell concluded that will “a planned pregnancy allows the health care provider as well as the woman to decide on the best plan for her individually … to lower fetal risk while keeping her seizures under optimal control.”

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