Men taking valproate no longer need sign off from two specialists
New guidance has been published around the prescribing of the epilepsy medication, valproate for men under the age of 55.
Following advice from the Commission on Human Medicines, the medicines and healthcare regulator, the MHRA has confirmed that men (males) in this category who are already taking valproate, will not need to see two specialists in order to remain on the medication.
However, men who are being initiated on valproate for the first time, will need to be reviewed by two specialists.
What the changes mean
- All men and women under the age of 55 who are being prescribed valproate for the first time, will need to have sign off from two specialists who independently consider and document that no other treatment options work.
- At their next annual specialist review, women and girls under the age of 55 receiving valproate should have their treatment reviewed using the revised Annual Risk Acknowledgement Form. At this review, if the patient has never been reviewed by two specialists either at initiation or annual review, a second specialist signature will be needed if the patient is to continue on valproate. Women do not need to be recalled for an additional review. Once a patient has received a treatment review by two specialists, subsequent annual reviews only require one specialist.
- Men under the age of 55 who are already receiving valproate can be prescribed the medication by a single prescriber without the need of a second specialist review. As a precaution, men and their female partners should use an effective contraception while taking valproate and for three months after stopping, to allow for one completed sperm cycle not affected by valproate. Men should not donate sperm when taking valproate or for three months after. If a woman is pregnant or planning a pregnancy with a a man who is on valproate, they should be referred for prenatal counselling.
Valproate risks during pregnancy
Babies exposed to valproate during pregnancy have a 1 in 9 risk of being born with a physical defect, while 3 or 4 babies in 10 risk having a neurodevelopmental disorder.
There is a much lower potential risk of neurodevelopmental disorders in around 5 in 100 babies when fathers take valproate in the 3 months before conception. Additional reproductive risks of valproate in male patients include infertility in humans and evidence of testicular toxicity in animals.
You should never stop taking valproate without first consulting your doctor as you may put yourself at risk of seizures.