Topiramate is a drug that is licensed for the prophylaxis of migraine and treatment of epileptic seizures in the United Kingdom. This medicine is available as tablets, oral solution plus capsules that can be swallowed whole or sprinkled on soft food. In a recent change of clinical guidance, this drug substance should no longer be prescribed to girls / women of childbearing age unless a pregnancy prevention protocol is in place. This is so as a full-scale safety review of this medicine, brand name Topamax®, indicated that following use in pregnancy there is scope for 2-3 times increased likelihood of intellectual disability, autism and attention deficit hyperactivity disorder presentation in the child. As such, the new advice from the Medicines & Healthcare products Regulatory Agency (MHRA) revolves around the fact that topiramate should not be prescribed during pregnancy for migraine prophylaxis or epilepsy management unless there is no other alternative for the patient at hand.
Key aspects of the new topiramate pregnancy prevention protocol concern the use of birth control during treatment with this drug substance alongside the requirement of a pregnancy test before treatment initiation. Prescribers are also required to verbally outline the risks associated with topiramate use in pregnancy and ask the individual concerned to complete a risk assessment form, signed to confirm understanding. The approach closely reflects that of the sodium valproate pregnancy prevention programme released several years ago in the United Kingdom. Support for effective birth control measures can be obtained from the healthcare team in the primary care setting (e.g. trained Nurses or General Practitioners). This latter point underscores the importance of a streamlined and effective multidisciplinary team to support patient care. Regular review of topiramate (i.e. yearly checks) use can be undertaken by appropriately trained Pharmacists, for instance. Moreover, all healthcare professionals concerned can refer to freshly released safety and educational materials that have been targeted specifically at the patient population. Overall, the implementation of this new clinical protocol will improve the safety profile around the prescribing of topiramate in the clinical space and hence reduce the number of topiramate exposed pregnancies.
It is important to note that women who are planning to become pregnant and using topiramate should not stop taking the drug without consulting their prescriber. This is so as potential exists for epileptic seizures to present once again, increase in their frequency or duration. This is obviously undesirable due to the negative health impacts on the patient and potentially for those people around them. If planning to conceive a child, then the female patient concerned should engage with their prescriber to discuss options. For example, potential exists for the patient to be switched to other antiepileptic medicines such as lamotrigine and levetiracetam. These medications have been considered safe by the Commission on Human Medicines in 2021 (i.e. both are not linked to birth defects when used in pregnancy). As time progresses there will be updates on product literature and packaging (i.e. visual warning symbols) to outline the issues around drug use during pregnancy. Clearly, as per any drug, any suspected adverse drug reactions from clinical application should be reported to the MHRA via the Yellow Card Scheme that can be ready accessed via the electronic version of the British National Formulary (e-BNF).
The Topamax product that is now subject to pregnancy prevention protocol measures.