Valproate safety material and warning about risk to babies’ birth weight

Updated safety and educational materials have been published for the anti-seizure medication valproate*.

You should never stop taking valproate without first consulting your doctor.

The updates include important new information about the higher risk of babies being born with a lower birth weight for gestational age when exposed to valproate.

This follows several studies which reported a decrease in mean birth weight and a higher risk of a low birth weight (less than 2,500gms), or small for gestational age for babies exposed to valproate. This is in comparison with those exposed to lamotrigine or not exposed to anti-seizure medications.

The materials also support the latest regulatory measures for the prescribing of valproate to both women and men under the age of 55.

You can find the information from the MHRA (Medicines and Healthcare products Regulatory Agency) here. 
 

Advice around valproate for women and men under 55

In summary:

• do not stop taking valproate without advice from a specialist. This is because
  epilepsy may worsen without treatment
• women and girls who are able to have children and who are taking valproate must
  follow the conditions of the Pregnancy Prevention Programme
• as a precaution it is recommended that male patients taking valproate should use
  effective contraception (condoms, plus contraception used by the female sexual
  partner) throughout the valproate treatment period and for 3 months after stopping
  valproate
• if you are on valproate, please attend any offered appointments to discuss your
  treatment plan and talk to a healthcare professional if you are concerned. If you wish
  to discuss family planning, please contact a healthcare professional
• consult the Patient Information Leaflet and Patient Guide for men or Patient Guide for
  women for information about the risks of valproate – also the MHRA information page
  for information resources. 
   

*Valproate is also prescribed as Belvo, Convulex, Depakote, Dyzantil, Epilim, Epilim Chrono or Chronosphere, Episenta, Epival, and Syonell.