Seizure Drug Used in Pregnancy Boosts Baby’s Autism Risk

Seizure Drug Used in Pregnancy Boosts Baby’s Autism Risk

Children born to mothers who took the anti-seizure drug valproate were five times more likely to be born with autism than those whose mothers didn’t take the medication, a Danish study found.

The epilepsy drug was also tied to a three-fold increase of autism spectrum disorder, which includes Asperger syndrome and other developmental disorders, according to research published yesterday in the Journal of the American Medical Association.

The findings show that valproate should be avoided and other treatments used instead to control seizures in women of childbearing age to reduce risk of autism in their unborn children, said Kimford Meador, a neurologist who wrote an accompanying editorial. If not, only the lowest dose of the drug should be given. Previous research has linked valproate’s use during pregnancy to heart defects, spina bifida, cleft palates and cognitive problems including lower intelligence scores.

“This is an important risk factor and one that can be avoided or at least the risk reduced in women who don’t need to take this and can take another drug,” Meador, a professor of neurology at Emory University in Atlanta, said in a telephone interview. “This is the strongest evidence to date that there is a link between fetal exposure and childhood autism or autism spectrum disorder.”AbbVie Inc. (ABBV), based in North Chicago, Illinois, sells valproate under the brand name Depakote. The drug is approved by the U.S. Food and Drug Administration to treat seizures, prevent migraine headaches and treat manic episodes associated with bipolar disorder. It is also used by doctors off-label for other conditions, particularly psychiatric disorders, according to the FDA website.

Agency Warning

The agency in 2011 warned women of childbearing age that valproate was associated with lower cognitive scores in children whose mothers took the drug during pregnancy. It had previously warned that the medicine was linked to birth defects.

Valproate may turn on genes in the body too much, not at all or at the wrong time, which could ultimately change the way the nervous system develops, said Christopher Stodgell, an associate professor in the Department of Obstetrics and Gynecology at the University of Rochester Medical Center in New York, who wasn’t an author on the paper but is studying the drug’s connection to autism.

The effects seem to occur early in pregnancy, within the first few weeks, sometimes before a woman even realizes she’s pregnant, Stodgell said.

‘Understand’ Risks

“The risks outweigh the benefits but the caveat is the drug is important to some women,” he said in a telephone interview. “It’s important that these women understand what those risks are.”

The study was one of the largest to show valproate’s link to autism, he said.

Researchers from Aarhus University Hospital looked at children born in Denmark from 1996 to 2006 and identified those exposed to valproate during pregnancy. The analysis included 655,615 children.

During the course of the study, 5,437 children were diagnosed with autism spectrum disorder, including 2,067 who were diagnosed with childhood autism. Of those, 508 were exposed to valproate.

In 14 years of follow up, use of valproate during pregnancy was associated with an absolute risk of 4.42 percent for autism spectrum disorder and 2.5 percent for childhood autism, compared with a total risk of 1.53 percent for autism spectrum disorder and 0.48 percent for childhood autism, the study showed.

Study Findings

When the researchers limited it to just children of women with epilepsy, 432 children were exposed to valproate. The absolute risk for developing autism spectrum disorder was 4.15 percent and the risk for childhood autism was 2.95 percent. That compares to 2.44 percent risk for autism spectrum disorder and 1.02 percent risk for childhood autism for the 6,152 children not exposed to valproate, according to the paper.

Meador said more studies are needed to better understand how seizure drugs and other treatments affect an unborn child.

“There’s still a great deal of valproate being used,” Meador said. “The amount being used in women of childbearing age seems to be excessive given the risk benefit ratio. There’s alternative drugs that have lower risks than valproate.”

To contact the reporter on this story: Nicole Ostrow in New York at

About bambooinnovator
Kee Koon Boon (“KB”) is the co-founder and director of HERO Investment Management which provides specialized fund management and investment advisory services to the ARCHEA Asia HERO Innovators Fund (, the only Asian SMID-cap tech-focused fund in the industry. KB is an internationally featured investor rooted in the principles of value investing for over a decade as a fund manager and analyst in the Asian capital markets who started his career at a boutique hedge fund in Singapore where he was with the firm since 2002 and was also part of the core investment committee in significantly outperforming the index in the 10-year-plus-old flagship Asian fund. He was also the portfolio manager for Asia-Pacific equities at Korea’s largest mutual fund company. Prior to setting up the H.E.R.O. Innovators Fund, KB was the Chief Investment Officer & CEO of a Singapore Registered Fund Management Company (RFMC) where he is responsible for listed Asian equity investments. KB had taught accounting at the Singapore Management University (SMU) as a faculty member and also pioneered the 15-week course on Accounting Fraud in Asia as an official module at SMU. KB remains grateful and honored to be invited by Singapore’s financial regulator Monetary Authority of Singapore (MAS) to present to their top management team about implementing a world’s first fact-based forward-looking fraud detection framework to bring about benefits for the capital markets in Singapore and for the public and investment community. KB also served the community in sharing his insights in writing articles about value investing and corporate governance in the media that include Business Times, Straits Times, Jakarta Post, Manual of Ideas, Investopedia, TedXWallStreet. He had also presented in top investment, banking and finance conferences in America, Italy, Sydney, Cape Town, HK, China. He has trained CEOs, entrepreneurs, CFOs, management executives in business strategy & business model innovation in Singapore, HK and China.

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