A popular “essential” medicine may be putting unborn babies at risk

• The World Health Organization lists valproate as an essential medicine, yet the drug can lead to serious neurodevelopmental disorders when taken during pregnancy.
• Findings show that access to antiseizure treatments is improving in many low- and middle-income countries, although prescribing practices are not consistently safe.

Growing Access to Seizure Medicines and New Safety Concerns

A study conducted with support from the World Health Organization has revealed that although more people in low- and middle-income countries are gaining access to antiseizure medications, these treatments are not always being used in ways that protect patient safety.

Dr. Adrienne Chan and Professor Ian Wong examined antiseizure medication trends across 73 countries from 2012 to 2022. They note that the increasing availability of these medicines suggests progress in access to essential neurological treatments. However, they also found that valproate remains the most commonly used option, even though it can lead to birth defects and neurodevelopmental issues when taken during pregnancy. Reported problems include spina bifida, cleft palate, and a range of intellectual, communication, behavior and memory disorders.

WHO Flags Valproate as a Major Global Risk

The World Health Organization (WHO) includes valproate on its list of "essential medicines." Despite this, the agency advises against its use for women and girls who could become pregnant because of the potential for birth defects. WHO has identified disorders linked to prenatal valproate exposure as a serious worldwide concern.

Uneven Global Progress in Safe Prescribing

The study's authors say there is an urgent need for widespread education to ensure that healthcare providers understand the risks and can offer safer alternatives when appropriate. In many higher-income countries, stricter regulations and pregnancy prevention programs have led to declines in valproate use. In other regions where newer antiseizure therapies remain too costly or difficult to obtain, valproate is still prescribed more often.

The WHO commissioned this research to support its broader goal of promoting safe, fair, and consistent access to essential neurological medicines around the world.

Next Steps to Protect Patients and Future Children

The study relied on sales data from each participating country. The researchers state that further work is needed to examine how these medicines are being used within specific populations and to assess whether safety guidelines are actually being followed. This will help clarify how often these drugs are being prescribed to women of childbearing age and what risks this may pose to unborn children.

Dr. Chan said:

"Our findings show that access to antiseizure 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."