MHRA Drug Safety Update: Valproate use in men
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued precautionary guidance regarding the of use of valproate in men.
This follows results from a retrospective observational study which indicated a possible association between valproate use by men around the time of conception and an increased risk of neurodevelopmental disorders in their children. Male patients who may father children should be informed of this possible increased risk and the recommendation to use effective contraception during valproate treatment and for at least 3 months after stopping valproate.
The new advice provided here is in addition to the measures published in a previous MHRA Drug Safety Update relating to the introduction of the prescribing requirements in patients under 55 years of age (female and male).
Patients should not stop taking valproate without talking to their healthcare professional.
Advice for healthcare professionals:
- inform male patients (of any age) who may father children of the possible risk at initiation of valproate or at their next regular treatment review – this counselling should be given irrespective of the indication for valproate and also after intravenous use of valproate
- as a precaution, recommend that male patients use effective contraception (condoms, plus contraception used by the female sexual partner) throughout the valproate treatment period and for 3 months after stopping valproate, to allow for one completed sperm cycle not exposed to valproate
- at the next regular treatment review, discuss with men on oral valproate treatment whether they are planning a family in the next year and if they are, refer to a specialist to discuss alternative treatment options
- if a female patient reports they are pregnant or planning a pregnancy with a man on valproate (including those undergoing IVF), refer for prenatal counselling
- advise men not to donate sperm during valproate treatment and for 3 months after stopping valproate
- report any suspected adverse drug reactions associated with valproate on a Yellow Card
Information for healthcare professionals to provide to patients:
- if you father a child while you are taking valproate or in the 3 months after stopping valproate, there is a potential small increased risk of the child being diagnosed with a mental or movement related developmental disorder (neurodevelopmental disorder)
- advice will be added to the valproate patient guide; in the meantime see MHRA’s and
Advice for healthcare professionals to provide to patients:
- it is recommended that you and your female sexual partner should both use effective birth control (condoms and another form of female contraception) as a precaution while you are taking valproate and for at least 3 months after stopping valproate
- allow at least 3 months to pass after stopping valproate before trying to father a child
- you should not donate sperm whilst taking valproate and for 3 months after stopping
- do not stop taking valproate unless you are advised to do so by a healthcare professional
- report any suspected adverse drug reactions associated with valproate on a Yellow Card
For further details, please view the full Drug Safety Update here.
