MHRA bans topiramate for pregnant patients

A recent study has highlighted significant risks associated with the use of topiramate during pregnancy, leading to new safety measures implemented by the UK Medicines and Healthcare products Regulatory Agency (MHRA). The study, published in May 2022 in JAMA Neurology, found that children born to mothers who took topiramate during pregnancy have a two to three times higher risk of developing intellectual disabilities, autism spectrum disorders, and attention deficit hyperactivity disorder (ADHD).

Topiramate, known by brand names such as Topamax, is used to treat epilepsy and prevent migraines. According to NHS England, it is prescribed to over 30,000 women under 55 each month in England. Given the findings from the study, the MHRA launched a review of the drug's safety in July 2022 and issued a drug safety update.

Following recommendations from the Commission on Human Medicines (CHM), the MHRA now advises that topiramate should not be prescribed for epilepsy during pregnancy unless no other suitable treatment options are available. Furthermore, a “Pregnancy Prevention Programme” has been introduced. This programme mandates women of childbearing age to use effective contraception during treatment and to take a pregnancy test before starting the medication. Patients are also required to complete a risk awareness form.

The risks associated with topiramate are not new; it was already advised against for migraine treatment during pregnancy due to the risk of birth defects such as cleft lip and palate, and reduced gestational age. The US Food and Drug Administration (FDA) has also recognized these risks in its labeling for topiramate.

In September 2023, the European Medicines Agency’s (EMA’s) Pharmacovigilance Risk Assessment Committee (PRAC) recommended additional measures to prevent fetal exposure to topiramate. Similar to the UK, the EMA has a pregnancy prevention programme in place to ensure women are adequately informed of the risks and take necessary precautions.

As a related development, the National Institute for Health and Care Excellence (NICE) in April 2024 issued guidance recommending AbbVie’s migraine medication Aquipta (atogepant) for adults in England. However, like topiramate, Aquipta is also not advised during pregnancy as per the EMA’s guidance.

These new safety measures underscore the importance of careful medication management and informed decision-making for women who are pregnant or may become pregnant. The goal is to minimize potential neurodevelopmental risks to the unborn child while ensuring that women with epilepsy or severe migraines have access to effective treatments. Healthcare professionals play a crucial role in balancing these needs and ensuring that patients are fully aware of the potential risks and necessary precautions when using topiramate.