A well known “essential” medicine is likely to expose unborn babies to danger

By Morgan Nwanguma


A sweeping analysis across 73 countries shows that while access to anti-seizure medications is improving globally, safe prescribing practices are not advancing at the same pace. Valproate, long associated with severe birth defects, continues to be widely used in many regions despite strong World Health Organization (WHO) cautions. Limited availability of safer, newer alternatives leaves millions potentially vulnerable. Researchers are now calling for urgent worldwide education efforts and tighter prescribing safeguards.

The study, led by Dr. Adrienne Chan and Professor Ian Wong of Aston University, examined global patterns in the use of anti-seizure medicines between 2012 and 2022. Their findings highlight an important contradiction:

The WHO classifies valproate as an essential medicine, yet the drug carries a significant risk of neurodevelopmental harm when taken during pregnancy.

Access to anti-seizure medications is expanding, particularly in low-and-middle-income countries, but prescribing habits remain inconsistent and, in many places, unsafe.

Rising Access, Persistent Safety Risks

Supported by the WHO, the research shows that growing availability of seizure treatments represents real progress in neurological care worldwide. However, it also reveals a troubling trend: valproate remains the dominant choice in many countries, even for women of childbearing age.

The risks associated with prenatal exposure to valproate are well-documented, including spina bifida, cleft palate, and a wide spectrum of intellectual, behavioral, communication, and memory disorders.

The researchers warn that without stronger safeguards, improved access to medications may inadvertently increase preventable harm. They stress the need for global action to ensure that expanding availability of anti-seizure drugs is matched by equally robust safety practices.

WHO Highlights Valproate as a Significant Global Safety Concern

Although the World Health Organization (WHO) lists valproate among its essential medicines, the agency strongly cautions against its use in women and girls who could become pregnant due to its well-established risk of causing birth defects. WHO now regards the disorders associated with prenatal valproate exposure as a major global public-health issue.

Uneven Progress in Safe Prescribing Practices

The study’s authors emphasize the urgent need for broad education efforts to ensure that clinicians fully understand these risks and can choose safer alternatives when possible. While many high-income countries have reduced valproate use through stricter regulations and pregnancy-prevention programmes, the picture is different elsewhere. In regions where newer, safer anti seizure therapies remain difficult to access or unaffordable, valproate continues to be used far more frequently.

The WHO commissioned this analysis as part of its ongoing effort to improve the safety, equity, and consistency of neurological treatment worldwide.

Next Steps to Protect Patients and Future Children

Using national sales data from all participating countries, the researchers note that additional investigation is needed to understand how anti-seizure medicines are being prescribed within specific groups. They stress that identifying whether current safety guidelines are being followed, especially regarding women of childbearing age, will be crucial in assessing the potential risks to future pregnancies and in guiding stronger protective measures.

Dr. Chan had this to say: “Our findings show that access to anti-seizure medicines is expanding globally, which is good news for patients who previously had little or no treatment options. But the continued widespread use of valproate in some parts of the world is concerning, given its known risks during pregnancy. Greater global alignment on safe prescribing and education is urgently needed to protect future generations.”

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