While access to essential anti-epileptic medications is increasing worldwide, a new international study highlights potential risks for pregnant women and developing babies. The analysis, coordinated by Aston University and commissioned by the World health organization, reveals continued use of valproate – a drug linked to significant birth defects and developmental issues – particularly in low- and middle-income countries. The findings underscore a critical gap between expanding treatment access and ensuring patient safety, prompting calls for standardized prescribing practices and greater awareness of the drug’s risks.
Access to medications for controlling seizures is expanding globally, but a new international study raises concerns about significant risks associated with one commonly used drug during pregnancy.
A study, conducted in collaboration with the World Health Organization (WHO), and recently published in the journal eClinicalMedicine, part of The Lancet group, shows that between 2012 and 2022, the use of anti-epileptic drugs increased significantly across 73 low- and middle-income countries. This expansion provides vital treatment options for patients who previously had limited access to care.
However, the analysis, coordinated by researchers at Aston University in the United Kingdom, indicates that this increased access isn’t always accompanied by adequate safety measures.
The primary concern highlighted by the authors is the continued use of valproate, a frequently prescribed anti-epileptic medication in many regions. While valproate remains on the WHO’s list of essential medicines, it is known to carry substantial risks during pregnancy, potentially causing birth defects such as spina bifida and cleft palate, as well as cognitive, behavioral, and memory impairments in children exposed to the drug in utero. These findings underscore the importance of carefully weighing the benefits and risks of medication use during pregnancy.
The WHO has warned for several years about these effects and recommends avoiding the prescription of valproate to women and adolescents of childbearing potential. The drug is banned or strictly regulated in numerous high-income countries.
In those countries, preventative programs and access to newer anti-epileptic medications have significantly reduced the use of valproate-containing drugs. Conversely, in many resource-limited countries where alternative options are expensive or difficult to obtain, the medication remains widely used.
The study, commissioned by the WHO, is based on nationally reported sales data to evaluate prescribing patterns. This information is crucial for determining the extent to which women of childbearing age are exposed to these risks and how effective prevention systems are in each country.
Experts emphasize that expanding access to anti-epileptic drugs is an important advancement for millions of patients, but they caution that the continued use of valproate without adequate information and controls remains a public health issue.
Researchers are calling for a global harmonization of prescribing practices for valproate-containing medications, along with educational programs for healthcare professionals and patients, to reduce risks to future generations.
In the European Union, medications containing valproate have recently been reevaluated by experts at the European Medicines Agency (EMA).
The Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh), a regulatory body representing EU member states, has decided to strengthen warnings regarding the use of valproate-based medications in women and adolescents due to the risk of birth defects and developmental problems in babies exposed during pregnancy.
The goal of these warnings is to ensure that patients are aware of the risks and that the medication is used only when absolutely necessary.
As a result, doctors in the EU are advised not to prescribe valproate for epilepsy or bipolar disorder to pregnant women, women who may become pregnant, or adolescents, unless other treatments are ineffective or not tolerated.
Patients for whom valproate is the only therapeutic option for epilepsy or bipolar disorder must be informed about the need to use effective contraception, and treatment should be initiated and monitored by a physician experienced in managing these conditions.
