Migraine and antiseizure medication topiramate (Topamax) must no longer be prescribed to women and girls unless they fulfil the requirements of a Pregnancy Prevention Programme.

The move follows a major safety review triggered by a study conducted in Europe. Findings from studies examining the risks associated with the use of topiramate during pregnancy 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.

Healthcare professionals are being advised that topiramate should not be used in pregnancy for the prophylaxis of migraine, or in pregnancy for epilepsy unless there is no other suitable treatment.

It should only be used in women of childbearing potential if a Pregnancy Prevention Programme is in place. This should ensure that such women are using effective contraception, have taken a pregnancy test to exclude pregnancy before starting topiramate, and are aware of the risks from its use.

Health care professionals should advise patients that the new measures are being introduced because there is evidence that taking topiramate during pregnancy can increase the risk to the baby of congenital malformation, low birth weight, intellectual disability, autistic spectrum disorder and attention deficit hyperactivity disorder.

Patients should use effective contraception) at all times during treatment with topiramate and for at least 4 weeks after the last dose, and be aware that it may interact with some hormonal contraceptives.

If a patient thinks she is pregnant and is taking topiramate for epilepsy, do not stop using it as this may cause seizures to start again or happen more often and last longer.  If the patient suspects pregnancy and is taking topiramate for migraine, she should stop immediately.

Topiramate is thought to be prescribed to just over 30,000 female patients under the age of 55 in England each month, according to the latest data from NHS England.

The topiramate product information leaflet is being updated to 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.