Concerns Rise Over Continued Use of Valproate Despite known Pregnancy Risks
A recent study, coordinated by researchers at Aston University in Grate Britain, highlights a concerning disparity: while access to anti-epileptic drugs is expanding globally, adequate safety measures aren’t consistently keeping pace. The primary concern identified by the study centers on the continued prescription of valproate, a widely-used antiepileptic medication.
Despite being listed as an essential medicine by the World Health association (WHO), valproate carries notable risks during pregnancy. Exposure to the drug during fetal advancement can lead to congenital malformations, including spina bifida and palatoschisis (cleft palate), as well as cognitive, behavioral, and memory impairments in children.
The WHO has issued warnings for several years regarding these effects, recommending against prescribing valproate to women and adolescents of childbearing age. Many high-income countries have responded by prohibiting or strictly regulating its use, coupled with pregnancy prevention programs and increased access to newer generation antiepileptics.
However, the situation differs significantly in resource-limited countries. Due to the expense or inaccessibility of alternative treatments, valproate remains a commonly prescribed option. The Aston University study, commissioned by the WHO, analyzed national sales data to assess prescribing patterns and the extent to which women of childbearing age are exposed to these risks, and the effectiveness of preventative measures.
Experts emphasize that increased access to anti-epileptic drugs is a positive development for patient care, but the continued use of valproate without sufficient safeguards represents a significant public health challenge.Researchers are advocating for globally standardized prescribing practices, alongside comprehensive education initiatives for both healthcare professionals and patients, to minimize risks to future generations.
Recent reevaluations of valproate-containing medications have also taken place within the European Union. The European Medicines Agency (EMA) and the Coordination Group for Mutual recognition and Decentralized Procedures – Human (CMDh) have strengthened warnings regarding valproate use in women and adolescents, citing the risk of malformations and developmental problems in babies exposed in utero.
These intensified warnings aim to ensure patients are fully informed of the risks and that the drug is reserved for situations where it is absolutely necessary. EU physicians are now advised not to prescribe valproate for epilepsy or bipolar disorder to pregnant women,those who may become pregnant,or adolescents,unless alternative treatments have proven ineffective or are not tolerated.
For patients where valproate remains the only viable therapeutic option, effective contraception is crucial, and treatment should be managed by a physician experienced in these conditions.
