Medicines containing topiramate are registered for the treatment of epilepsy and for the prevention of migraine. Topiramate is known to cause birth defects in the baby if used during pregnancy. The European Medicines Agency’s (EMA) Risk Assessment Committee (PRAC) reviewed all available information, including the recently published results of three observational studies. Two of these studies found an approximately two- to threefold increased risk of neurodevelopmental disorders in children of epileptic mothers who were treated with topiramate during pregnancy compared to children of epileptic mothers who did not take any medication. These disorders included autism spectrum disorders, intellectual disabilities or attention deficit hyperactivity disorder (ADHD). At the same time, the already known risk of birth defects and reduced birth weight of children related to the treatment of mothers with topiramate during pregnancy was confirmed.
In order to reduce the risk of topiramate affecting the fetus, the PRAC recommended an extension of the already existing measures that must be followed during topiramate treatment:
- topiramate for the treatment of migraine is already contraindicated in women of childbearing age who are not using effective contraception;
- topiramate for the treatment of epilepsy will be contraindicated in women of childbearing age who are not using effective contraception. The exception is women for whom no other treatment is suitable and who are aware of the risks.
In addition, for topiramate, the so-called pregnancy prevention program, which aims to inform women about the risks of topiramate to the unborn child and the need to prevent pregnancy during treatment. Both doctors and patients will be provided with educational materials in which the risks of topiramate treatment during pregnancy will be explained in detail. Each package of these medicines will also include a patient card and a warning printed on the medicine’s packaging. It will be the duty of the holders of decisions on the registration of drugs containing topiramate to evaluate the effectiveness of these measures through a drug utilization study .
Patients who are being treated with topiramate and are planning to become pregnant are advised to contact their attending physician. Treatment with topiramate should not be interrupted without a doctor’s recommendation.
If a patient treated with topiramate plans to become pregnant, the treatment should be discontinued. Effective contraception must be used for at least 4 weeks after the end of treatment.
Before starting treatment with topiramate in women of childbearing age, it is necessary to rule out pregnancy and educate the patient about the risks of topiramate for the fetus and the need to use effective contraception. The need for topiramate treatment is recommended to be periodically reassessed.
Doctors prescribing medicines containing topiramate will be informed about the new measures in a targeted manner, also called direct communication with healthcare workers.
Reference
https://www.ema.europa.eu/en/news/prac-recommends-new-measures-avoid-topiramate-exposure-pregnancy
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