The UK’s Medicines and Healthcare Regulatory Agency (MHRA) has warned men taking epilepsy medication valproate and their partners to use effective contraception, due to risks associated with neurodevelopmental disorders in children.
The guidance tells patients and their partners that they should take effective measures during treatment with valproate and three months after stopping the drug. Patients should not donate sperm during valproate use and three months after treatment either.
Valproate is prescribed under various brand names, including Sanofi’s Depakine (sodium valproate), and Abbott’s Depakote (divalproex sodium). It is mainly prescribed for the treatment of epilepsy; however, it can also be used to treat bipolar disorder.
This announcement comes a few months after a study, commissioned by the European Medicines Agency, raised flags regarding a potential heightened risk of neurodevelopmental disorders in children fathered by men on valproate around conception.
The data from the study indicated that approximately five out of 100 children born to fathers treated with valproate during conception were diagnosed with a neurodevelopmental disorder, in contrast to three out of 100 children whose fathers were on Lamictal (lamotrigine) or Keppra (levetiracetam), two other anti-seizure medicines.
The MHRA previously published guidance on medicines containing valproate in October 2023. Following this, the original pack dispensing medicines containing valproate was designed to inform patients about the risks to an unborn baby.
Additionally, since January 2024, new measures recommended that valproate must not be started in new male or female patients younger than 55 years of age unless two specialists independently consider and document that there is no other effective or tolerated treatment, or unless there are compelling reasons that the reproductive risks do not apply.
The heightened risk of neurodevelopmental disorders is an issue that has previously landed Sanofi in court. The drugmaker was ordered to pay more than $400,000 in damages in May 2022 after a French court ruled Sanofi at fault due to inadequate labelling information for Depakine. The damages were paid to a family that was not made aware of the potential for birth defects related to its drug Depakine.
In the announcement accompanying the latest guidance, MHRA's chief safety officer Alison Cave said: “While the risk to a child is lower than the risk associated with a mother taking valproate in pregnancy, we recommend that men taking valproate and their partners follow the updated guidance and use effective contraception.”
