A global health paradox: Epilepsy drug access rises, but so do risks for unborn babies

• A major global review finds access to antiseizure medicines is increasing, but safe prescribing lags.
• Valproate, a drug linked to severe birth defects, remains the most widely used antiseizure medication worldwide.
• The WHO advises against valproate for women who could become pregnant.
• Disparities persist: wealthier nations have reduced valproate use, but low- and middle-income countries still rely on it heavily.
• Researchers call for urgent global education and stronger safeguards to protect future generations.

In a troubling paradox for global neurology, access to essential epilepsy medications is expanding worldwide, yet a commonly prescribed drug known to cause severe birth defects remains persistently overused. A landmark study from Aston University, analyzing data from 73 countries between 2012 and 2022, reveals that while more patients are receiving treatment, the widespread prescription of valproate continues to pose a significant threat to women of childbearing age and their future children. This research, supported by the World Health Organization (WHO), underscores a critical disconnect between drug availability and safe prescribing practices, highlighting an urgent need for global policy alignment and education to protect vulnerable populations.

A medicine deemed both essential and dangerous

The core of the issue lies with valproate (valproic acid), a drug included on the WHO’s Model List of Essential Medicines for its efficacy in controlling seizures. However, for nearly two decades, robust scientific evidence has linked prenatal exposure to valproate to a significantly increased risk of major congenital malformations and neurodevelopmental disorders. These can include physical defects like spina bifida and cleft palate, as well as lifelong cognitive, behavioral and memory impairments—a constellation of issues sometimes referred to as fetal valproate syndrome.

Despite clear WHO guidelines recommending safer alternatives like lamotrigine or levetiracetam as first-line therapy for women and girls of childbearing potential, the new study found valproate was the single most consumed antiseizure medication globally in 2022. Its essential medicine status, intended to ensure availability for those in need, may inadvertently contribute to its continued first-line use in regions where newer guidelines and safety protocols are slower to be implemented.

A tale of two worlds: Prescribing disparities across incomes

The global analysis paints a picture of stark inequality in neurological care. While overall consumption of antiseizure medications rose by an average of 2.58% annually, the rate in high-income countries was more than four times that of lower-middle-income nations. More critically, the trend in valproate use diverged sharply by economic region.

• In many high-income countries, stringent regulatory actions, pregnancy prevention programs and heightened professional awareness have successfully driven down valproate prescriptions for women.
• Conversely, in lower- and upper-middle-income countries, valproate consumption continued to grow at a stronger rate. Here, limited access to costlier newer-generation drugs, coupled with potential gaps in clinician education and regulatory oversight, means this higher-risk medication often remains a default option.

This disparity creates a double burden: Patients in poorer regions finally gain access to essential treatment, but may receive a drug that carries profound risks if pregnancy occurs, perpetuating a cycle of preventable harm.

A long-standing warning ignored

The dangers of valproate in pregnancy are not new. As early as 2006, studies published in journals like Neurology were quantifying the elevated risks, showing over 20% of valproate-exposed pregnancies resulted in fetal death or serious birth defects. For years, patient advocates and some medical professionals have campaigned for stronger warnings and stricter controls. The persistence of high global use a generation later points to systemic failures in translating well-established research into universal clinical practice and drug policy, especially in resource-limited settings.

The path forward: Aligning access with safety

The researchers, Dr. Adrienne Chan and Professor Ian Wong, emphasize that improving access to medicine is only half the battle. The next, more complex step is ensuring it is used safely and appropriately. Their study, based on pharmaceutical sales data, provides a macro-level view; they now call for deeper investigation into prescription patterns at the patient level to understand exactly how often valproate is being prescribed to women of childbearing age.

The solution requires a multi-pronged, globally coordinated effort. This includes:

• Intensified education for healthcare providers worldwide on valproate risks and safer alternatives.
• Strengthened regulatory frameworks to enforce safety guidelines.
• Initiatives to improve affordability and availability of newer, safer antiseizure medications in all countries.
• Empowered patient education so women can make fully informed choices about their treatment.

A call for conscience in global health

The expansion of treatment for epilepsy represents a hard-won victory in global health equity. However, the Aston University study serves as a crucial reminder that access without safety is an incomplete and potentially dangerous triumph. As the world moves to close the gap in neurological care, it must do so with a conscientious commitment to “first, do no harm.” Protecting future generations from preventable birth defects requires that global drug access programs and national prescribing habits evolve in lockstep with unequivocal safety evidence, ensuring that the medicine meant to heal does not inadvertently inflict lifelong damage.

Sources for this article include:

ScienceDaily.com

TheLancet.com

MirageNews.com