As part of the continuing efforts to reduce the risks associated with the anti-seizure medication (ASM), Topirimate (Topamax), the Health Products Regulatory Authority (HPRA) have recently reissued patient information materials and reminders to prescribers and pharmacists about their obligations under the Pregnancy Prevention Programme (PPP) and risk reduction measures associated with the medication.
Research in 2022 found that for children who were exposed to Topiramate monotherapy (i.e., no other ASM was used) during pregnancy, autism spectrum disorder presented in 4.3% of cases, while intellectual disabilities presented in 3.1% of cases. The findings of this research triggered a review by the European Medicines Agency of the current safety measures attached to the medication. In October 2023, the introduction of a Pregnancy Prevention Programme (PPP) was adopted by the Europeans Medicine Agency.
The key points of the PPP from an epilepsy perspective are as follows:
- Topiramate must not be used in pregnancy for women with epilepsy unless there is no suitable alternative treatment.
- Topiramate must not be used in patients with epilepsy unless the conditions of the PPP are met
To help support education and communication around the potential risks, a number of information resources were developed as part of the PPP to help educate patients, clinicians and prescribers.
There have been no updates to the information provided within these important documents. However, the materials being reissued is an important step in continuing to ensure that both patients and healthcare professionals are aware of the risks and the existence of a PPP for this medication. To read more about the PPP for Topirimate, and view the information materials, visit the ‘Women’ section of our website.
PLEASE CONTACT YOUR HEALTHCARE TEAM IF YOU HAVE ANY CONCERNS. DO NOT STOP TAKING TOPIRIMATE WITHOUT FIRST SPEAKING WITH YOUR PRESCRIBER.
If you need any information or support on your or your loved one’s journey with epilepsy, please do not hesitate to contact your local Community Resource Officer. Visit the ‘Our Local Service’ page on our website for details of your local Community Resource Officer.