MHRA Implements New Safety Measures for Topiramate (Topamax) Following European Study

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MHRA Implements New Safety Measures for Topiramate (Topamax) Following European Study

In response to a comprehensive safety review prompted by a recent European study, the Medicines and Healthcare Products Regulatory Agency (MHRA) is introducing enhanced safety protocols for topiramate, commonly known by its brand name Topamax.

Mhra Implements New Safety Measures For Topiramate (topamax) Following European Study

The Commission on Human Medicines (CHM) scrutinised research findings related to topiramate use during pregnancy. These studies revealed that children born to mothers who took topiramate faced a risk level approximately 2 to 3 times higher for intellectual disability, autism spectrum disorders, and attention deficit hyperactivity disorder.

Based on CHM recommendations, the MHRA now advises healthcare professionals against prescribing topiramate to treat epilepsy during pregnancy unless no suitable alternative exists. Additionally, topiramate should not be used during pregnancy for migraine due to its established link with an increased risk of birth defects.

To comply with the Pregnancy Prevention Programme, women of childbearing potential must use effective birth control throughout topiramate treatment and undergo a pregnancy test before starting the medication. Healthcare providers should inform patients about the risks associated with topiramate during pregnancy, and a risk awareness form is now part of the program.

Patients should also be aware that certain birth control methods are less effective when using topiramate. Consulting with a GP or sexual healthcare practitioner can help determine the most appropriate contraceptive method. Regular medication reviews, at least once annually, are recommended to ensure patient safety. New safety materials and educational resources have been introduced to support healthcare professionals and patients in implementing these measures.

Topiramate is commonly prescribed for migraine prevention and epilepsy management. According to the latest data from NHS England, it is administered to over 30,000 female patients under the age of 55 each month.

Before this review, topiramate was already associated with significant risks during pregnancy, including a higher likelihood of birth defects and low birth weight. The Pregnancy Prevention Programme aims to further enhance safety measures and reduce topiramate-related pregnancies.

Pregnant women or those planning to conceive who currently take topiramate for epilepsy should not discontinue the medication without consulting a specialist. Abrupt cessation may lead to increased seizure activity. Women planning to conceive should discuss treatment options with their GP.

In 2021, the CHM concluded that lamotrigine and levetiracetam were safer antiepileptic options during pregnancy, as they were not associated with birth defects.

Additional CHM recommendations include updating the topiramate product information leaflet to reflect available data on pregnancy risks. Furthermore, a visual warning symbol—a red circle with a line through a pregnant woman—will be added to all topiramate medicine boxes, accompanied by warning text.

Healthcare professionals and patients are encouraged to report suspected adverse drug reactions associated with topiramate to the Yellow Card scheme.


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