Summary: Recently, the UK MHRA has updated its guidelines, making it quite difficult for doctors to prescribe valproate to women and men below the age of 55. Valproate is often used to treat epilepsy, bipolar disorder, and sometimes even migraine. This update has been introduced due to concerns regarding continued in-utero exposure to the drug to a small number of newborns each year.
Experts are raising concerns regarding the safety of one of the commonly used anti-seizure drugs, and UK guidelines have been updated prohibiting the prescription of valproate to men or women younger than 55 years of age. So, should the US also consider updating its guidelines?
UK Medicines and Healthcare Products Regulatory Agency (MHRA) has issued new guidance that bans the use of valproate in male and female patients below the age of 55 unless two independent experts consider it necessary.
Valproate is not just used to manage seizures or epilepsy. It is also used to manage bipolar disorder. Additionally, it may be sometimes considered for managing migraine headaches.
However, there is a reason why regulatory agencies in the UK have updated their guidelines. Evidence has been accumulating that this drug causes congenital malformations or neural tube defects in children of mothers exposed to the drug. Not only that, it also seems to increase the risk of these inborn errors even if fathers have been exposed to drugs within three months of conception.
However, not everyone agrees with such strict guidelines. This drug is quite suitable for controlling seizures, and some researchers think that UK regulatory agencies have gone too far without taking into consideration various other factors.
In the US, it appears that guidelines are not changing. This is because experts say that it has been long known that valproate causes congenital disabilities, and some of the highly reliable studies were published more than 15 years ago.
Moreover, The American Epilepsy Society (AES) already has very clear guidelines. It prohibits the administration of the drug on women planning to get pregnant.
So, why have UK regulatory agencies come up with these recommendations? Well, it appears that there is a reason for that. Although previous guidelines regarding avoiding its prescription in women planning to get pregnant have helped, those have not been as effective as expected. Experts say that despite the reduction in valproate use in women of childbearing age, it remains a significant issue. Still, two to three babies are born in the UK each month who were exposed to this toxic drug in utero.
All this means that women are still not being adequately informed about the risks posed by this drug. Here, it is vital to understand that valproate has been in use for managing bipolar disorder and epilepsy for several decades, and it is generally quite safe. It isn’t safe in just a specific population group.
Health experts in the US think introducing a strict ban like in the UK is not a good idea. Since this will pose certain challenges for doctors, they say that doctors often prescribe this drug when other measures have failed. So, a strict ban regarding valproate may have negative consequences, too.
US experts say that they are well aware of the risks, as the first evidence regarding neural tube defects in newborn babies to mothers exposed to valproate emerged in the 1980s. This means that adequate guidelines are already in place to avoid the use of this drug in women who plan to get pregnant. Moreover, since the discovery of these side effects, valproate use has significantly declined in women living with epilepsy.
Further, experts note that introducing a ban like the UK means that doctors will have trouble prescribing this drug to those women who do not plan to have children anymore. Moreover, many women living with epilepsy may not want to get pregnant at all due to various reasons.
US experts are also skeptical about introducing such measures for men. Although there is a growing body of evidence about increased neurodevelopmental disorders in the offspring of men who took valproate three months before conception, most data come from weak retrospective observational studies.
To conclude, experts in the US say that they do not need to introduce the ban like in the UK, though they agree that there is a need to introduce stronger warnings for valproate.
