• MHRA Drug Safety Update (July 2022): Topiramate (Topamax): start of safety review triggered by a study reporting an increased risk of neurodevelopmental disabilities in children with prenatal exposure

• 10mg and 60mg tablets
  • Approved for preventing migraine in line with NICE:
    • they have 4 or more migraine days a month
    • at least 3 preventative drug treatments have failed
    • First 3 months supply from secondary care with a review at 3 months. If effective, transfer to primary care with a further 1 month supply from secondary care to allow for handover.

• Clonidine is not generally recommended for migraine prophylaxis; may aggravate depression/cause insomnia.

• 100mg/1ml concentrate for solution for infusion
  • Approved for the prevention of chronic migraine in adults in line with NICE only if
    • they have 4 or more migraine days a month
    • at least 3 preventative drug treatments have failed

• 70mg/1ml and 140mg/1ml solution for injection (pre-filled pens)
  • Approved for the prevention of chronic migraine in adults in line with NICE only if
    • they have 4 or more migraine days a month
    • at least 3 preventative drug treatments have failed

• 225mg/1.5ml solution for injection (Pre-filled pens/syringes)
  • Approved for the prevention of chronic migraine in adults in line with NICE only if
    • they have 4 or more migraine days a month
    • at least 3 preventative drug treatments have failed
    
    
    

• 120mg/1ml injection
  
  • Approved for the prevention of chronic migraine in adults in line with NICE only if
    • they have 4 or more migraine days a month
    • at least 3 preventative drug treatments have failed

• 75mg oral lyophilisates
  • Approved for preventing migraine in line with NICE 
    • First 3 months supply from secondary care with a review at 3 months. If effective, transfer to primary care with a further 1 month supply from secondary care to allow for handover.
    • Approved for treating migraine in line with NICE 

• Only approved for use in accordance with NICE guidance. 

• Note: sodium valproate 500mg & 1000mg MR granules (Episenta®) are also approved for use in those who have difficulty swallowing sodium valproate tablets. MR granules may be more convenient to use than large volumes of liquid formulations.

Black Triangle in Females

Valproate must no longer be prescribed to women and girls of
childbearing potential unless there is no alternative and they are on the
Pregnancy Prevention Programme (PPP)  

For information relating to alerts regarding valproate, including Drug Safety Updates and links to PPP materials, please use the following link:

MHRA Drug Safety Updates (valproate)

Valproate (Belvo, Convulex, Depakote, Dyzantil, Epilim, Epilim Chrono or Chronosphere, Episenta, Epival, and Syonell▼): new safety and educational materials to support regulatory measures in men and women under 55 years of age (MHRA Drug Safety Update January 2024)

Valproate use in men: as a precaution, men and their partners should use effective contraception (MHRA Drug Safety Update September 2024)

Valproate (Belvo, Convulex, Depakote, Dyzantil, Epilim, Epilim Chrono or Chronosphere, Episenta, Epival, and Syonell▼): review by two specialists is required for initiating valproate but not for male patients already taking valproate. (MHRA Drug Safety Update February 2025)