Following a major safety review triggered by a new study conducted in Europe, the MHRA is introducing new safety measures for topiramate, also known by the brand name Topamax.
The Commission on Human Medicines (CHM) looked at findings from studies examining the risks associated with the use of topiramate during pregnancy, which showed that children born to mothers who take topiramate during pregnancy face a risk level approximately 2 to 3 times higher of intellectual disability, autism spectrum disorders and attention deficit hyperactivity disorder.
Following recommendations made by the CHM, the MHRA is now advising healthcare professionals that topiramate should not be prescribed to treat epilepsy during pregnancy unless there is no suitable alternative treatment. Topiramate should already not be used during pregnancy for migraine because of the known link with an increased risk of birth defects…
