2023-09-05 18:01:36
The Spanish Agency for Medicines and Health Products (Aemps) has recommended that pregnant women not use medicines containing topiramate to prevent migraine or treat epilepsy, since newborns could have a increased risk of neurodevelopmental disorders.
The medicines that contain topiramate are currently used in the European Union to treat epilepsy and prevent migraine headaches, but in some countries the drug is also used in combination with phentermine to reduce weight.
The recommendations from the European Pharmacovigilance Risk Assessment Committee (PRAC), including one that says women should avoid becoming pregnant while taking the drug, emerge from a review of three recent observational studies.
Two of them suggest that children born to women who took topiramate-containing medicines during pregnancy may have a two to three times higher risk of neurodevelopmental disorders than children born to women with epilepsy, but not taking antiepileptic drugs. These disorders include autism spectrum disorders, intellectual disability, and attention deficit hyperactivity disorder (ADHD).
The PRAC also confirmed in another of the studies increased risk of congenital malformations and reduced growth of the fetus when mothers are exposed to topiramate during pregnancy. Birth defects occurred in four to nine out of 100 children born to women taking the drug, compared with a ratio of one to three out of 100 children born to pregnant women not taking the drug.
Furthermore, at least 18 out of 100 children were smaller and weighed less than expected at birth when the mothers had taken topiramate, compared with five in 100 babies born to mothers without epilepsy and not taking antiepileptic medicines.
The PRAC for its part recommends that those who use topiramate to treat epilepsy avoid doing so during pregnancy unless no other suitable treatment is available. In addition, it has published additional measures, in the form of a pregnancy prevention program, to prevent exposure of children to topiramate in utero. These measures will inform any woman or girl who may have children about the risks of the medicine during pregnancy and the need to avoid becoming pregnant while taking the medicine.
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