News » Clinical guidance news, MHRA alert » MHRA issues male valproate patient safety advice
January 15th 2024
Male patients taking valproate who are planning a family in the next year should talk to their healthcare professional about their treatment.
The precautionary measure follows revised studies on men taking valproate which concluded that there may be an increased risk of neurodevelopmental disorders in the children they father.
The study looked at men taking valproate in the three months prior to conception compared with men on other antiseizure medicines. Around five children in 100 born to fathers treated with valproate around conception were diagnosed with a neurodevelopmental disorder. This is compared to three in 100 children whose fathers were taking lamotrigine or levetiracetam around conception (two other anti-seizure medicines).
This risk is much smaller than the risk associated with valproate in pregnancy.
The MHRA says a revised valproate Annual Risk Acknowledgement Form for men aged under 55 will be introduced during 2024 to replicate measures for women of the same age. These measures include the need for a second opinion’s signature if the patient is to continue with valproate.
In November, new valproate safety measures highlighted that valproate must not be started in new patients (male or female) younger than 55 years, unless two specialists independently consider and document that there is no other effective or tolerated treatment, or there are compelling reasons that the reproductive risks do not apply. For the majority of patients, other effective treatment options are available.
In October 2023, original pack dispensing was introduced following a public consultation to ensure that the information on the risks of valproate reaches patients.
