After a major safety review triggered by a recent study in Europe, Britain’s Medicines and Healthcare Products Regulatory Agency (MRHA) has prohibited the dispensing of migraine and epilespy medication topiramate (brand name Topamax) to pregnant women and girls – unless they fulfil the requirements of a Pregnancy Prevention Programme.
This requires that women must take a pregnancy test before starting on the drug. It will also be updating its boxed product leaflet information.
The decision was taken after the Commission on Human Medicines (CHM) looked at findings showing that children born to women taking topiramate in pregnancy faced a two to three times higher risk of intellectual disability, autism spectrum disorders and attention deficit hyperactivity disorder.
The MHRA subsequently has advised professionals that topiramate should not be prescribed as an epilepsy treatment for expectant women unless there is no suitable alternative treatment.
The medication had already been red-flagged as a migraine treatment for pregnant women because of known, increased risks of birth defects.
Topiramate is taken to prevent migraines or for the management of seizures, and is thought to be prescribed to more than 30 000 female patients under 55 in England in one month, according to data from NHS England.
Before the recent review, topiramate was already known to have risks associated with significant harm during pregnancy, including a higher risk of birth defects and low birth weight. For this reason, patients were previously advised against using it during pregnancy and it was recommended they use highly effective contraception during treatment.
The introduction of the Pregnancy Prevention Programme will further strengthen the safety measures and aim to reduce the number of topiramate-exposed pregnancies, said the MHRA.
Other recommendations made by the CHM include updates to the topiramate product information leaflet, to fully reflect the available data on the risks of use during pregnancy.
A visual warning symbol will be added to the box of all topiramate medicines. This ‘no’ symbol will show a pregnant woman in a red circle with a line through it. This will be accompanied by warning text about the risks.
Gov.UK article – New pregnancy prevention measures introduced for topiramate (Open access)
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