MHRA Alert – Topiramate: New Pregnancy Prevention Programme Requirements

Important Safety Update: Topiramate (Topamax)

The MHRA has introduced new safety measures for topiramate following a comprehensive review of its use in pregnancy. Topiramate is now contraindicated in pregnancy and in women of childbearing potential unless strict conditions are met.

Key Points

• Topiramate carries a significant risk of birth defects and developmental disorders when used during pregnancy
• A formal Pregnancy Prevention Programme is now mandatory for all women of childbearing potential prescribed this medication
• Healthcare providers must ensure patients understand the risks and confirm appropriate contraception is in place
• Existing patients on topiramate should be reviewed to ensure they meet the new safety criteria

Affected Medications

• Topiramate (all formulations and strengths)
• Topamax (branded product)
• All generic equivalents

Recommended Actions

• Prescribers: Review all women of childbearing potential currently on topiramate. Discuss risks, benefits, and contraception requirements. Consider alternative treatments where appropriate.
• Patients: Do not stop taking topiramate without speaking to your doctor. If you are planning pregnancy or may become pregnant, contact your healthcare provider immediately.
• All responders: Be aware of this contraindication when assessing patients on topiramate, particularly in pre-hospital and emergency settings.

Further Information

Read the full MHRA drug safety update on the UK government website.