Medications for epilepsy linked to an increased risk of congenital malformations



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Two drugs used to control epileptic seizures – and prescribed to patients with migraine, pain, and bipolar disorder – are associated with an increased risk of birth defects, according to new research.

According to a study published Wednesday in Neurology, women who took valproic acid or topiramate during the first months of their pregnancy had a higher risk than usual of having congenital anomalies, including spina bifida and cleft lip.
Antiepileptic drugs, especially newer ones, are increasingly being prescribed for medical conditions unrelated to epilepsy. According to a 2018 study cited by researchers, the prevalence of use of drugs against epilepsy during pregnancy, for whatever reason, was 21.9 per 1,000 pregnant women in the United States, 6.7 per 1,000 in France and 4.3 per 1,000 in the Netherlands.

For this study, the researchers used data from the French health system to identify pregnancies that resulted in live births between January 2011 and March 2015. Of the 1,886,825 pregnancies, the researchers looked for use by mothers of 10 anti-epileptic drugs before and after conception and looked for 23 congenital anomalies in children born to these women.

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The researchers found that only one antiepileptic drug had been prescribed to 8,794 women.

Women receiving valproic acid (10.4% of the group of pregnant women receiving antiepileptic treatment) were 19 times more likely to have a baby with spina bifida than women not taking medication against epilepsy. Of the 913 women who were prescribed valproic acid, six babies (0.66%) had spina bifida, compared to 616 (0.03%) born to women who did not take any anti-HIV drug. ;epilepsy. Valproic acid also increased the risk of seven other congenital malformations, including a cleft palate and four types of heart defects.

Topiramate administered to women (5.9%) was seven times more likely to have a baby with a cleft lip (with or without cleft palate), the study said. Among the 517 women who received topiramate, three babies (0.60%) had a cleft lip, compared to 1637 babies (0.09%) born to women not taking medication for epilepsy.

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Lamotrigine, levetiracetam, carbamazepine, oxcarbazepine and gabapentin did not present a high risk of congenital malformations.

The researchers found weak signals binding clonazepam to a higher risk of microcephaly (a small head circumference associated with a low IQ), while phenobarbital and pregabalin individually were associated with higher risks of different types. heart defects. These associations were based on a very small number of babies and therefore could not be considered statistically significant, they said.

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Dr. David Ficker, Elected Chair of the Epilepsy Foundation's Professional Advisory Board, said the new study "confirms other large-scale studies in which similar findings have been found." It reinforces the risks associated with these two. drugs. "

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"We have been concerned about valproic acid for many years," said Ficker, who did not participate in the new research. He recalled a study in the early 2000s establishing an association between the drug and a higher risk of major birth defects. After these revelations, "the use of valproic acid in women of childbearing age has drastically decreased," he said.

There are different levels of care for patients with epilepsy, some treated by their primary care providers, others by neurologists and others still treated by epilepsy specialists – neurologists specially trained in the disease.

"In the community of epilepsy physicians, we are perfectly aware of the risks of valproic acid during pregnancy, and I think even in the community of neurologists," said Ficker, also a professor of neurology at the University of Toronto. the Gardner Neuroscience Institute of the University of Cincinnati. However, the primary care community may not recognize potential safety risks, he said.

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"I also know that some women with difficult-to-control epilepsy consider that valproic acid is the only drug that could be effective for them.All these drugs have different modes of functioning in the brain, and they do not are not necessarily completely interchangeable. "

"Fortunately, for many women, there are alternative medicines that offer a better safety profile during pregnancy," he said.

The recommendations of the Academy of Neurology recommend that physicians prescribe a drug that is safe for the developing fetus and, if possible, a single drug for the treatment of seizures: "If a person takes more than one medicine for the treatment of seizures, the risk of congenital malformations increases. "Said Ficker.
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Nevertheless, it is important to control seizures because they also pose risks – such as falls, miscarriages, oxygen reduction to the fetus, and fetal distress – for a developing baby. he declares.

In the end, Ficker warns women with epilepsy of childbearing or pregnant age "do not stop taking your medications without consulting your doctor".

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Page Pennell, president of the American Epilepsy Society, agreed that the findings of the study were not new because most of these associations between the use of antiepileptic drugs during pregnancy and congenital anomalies were based on "numerous studies" of populations in North America, Australia, and others. countries of Europe.

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Yet previous studies have found links to other negative associations, writes Pennell in an email: "Most noteworthy, the use of valproic acid during pregnancy has been associated with a higher risk of low IQ, d autism and autistic spectrum disorder and need for special education in children exposed during pregnancy Topiramate has also been associated with an increased risk of low birth weight. "

Although the evidence is not substantial, she also highlighted the "relatively new findings" of the study relating to an association with the use of clonazepam, microcephaly, pregabalin and a cardiac abnormality. According to the study, 11.1% of women who received antiepileptic treatment had received a script for clonazepam and 19.0% for pregabalin.

The new research also suggests that neurologists ensure that patients of childbearing age take additional folic acid, "which has been associated with a reduced risk of neurodevelopmental disorders, including autism, in the children of women with epilepsy, "Pennell said.

Like Ficker, she recommends counseling young women on antiepileptic drugs because "more than 50% of pregnancies are unplanned in the US", and women taking antiepileptic drugs still have an unplanned pregnancy rate high risk.

However, not all these pregnancies are due to a lack of foresight. Carbamazepine, she explained, and some of the other seizure medications may interact with birth control and "may increase the rate of unplanned pregnancies."

At doses greater than 200 milligrams a day, topiramate may also decrease the effectiveness of some hormonal contraceptives.

Pennell concluded that "a planned pregnancy allows the health care provider and the woman to decide the best plan for her individually … in order to reduce the fetal risk while keeping her seizures under optimal control."

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