Provides information about a review into the safety of topiramate, which will look at possible harms in the learning and development of children whose mothers took topiramate during pregnancy.
Topiramate’s effect on pregnant mothers is being reviewed by Medicines and Healthcare Regulatory Agency
Epilepsy and migraines are both treated with topiramate. It is specifically used for:
to treat seizures in adults and children older than age 6 with additional medications to treat seizures in adults and children aged 2 years and over to prevent migraine headaches in adults after considering potential alternative treatments alone to treat seizures in adults and children older than age 6
Only under the direction of a medical practitioner should it be prescribed.
Topiramate use during pregnancy is already known to negatively affect the growth and development of an unborn child.
Therefore, it should be common knowledge for women to utilise very efficient birth control while taking topiramate and to refrain from getting pregnant while doing so.
Other pregnancy medications, such as lamotrigine and levetiracetam, are safer for the unborn child.
Information indicates that, when compared to the general population, these medications do not raise the incidence of physical birth defects.
Following an observational research that suggested a possible increased risk of neurodevelopmental problems (including autistic spectrum disorder and impacts on learning and development) in children exposed to topiramate during pregnancy, a safety review of the drug is currently being conducted.
If a woman on topiramate wants to become pregnant, she should talk to her doctor about alternative treatments, but she shouldn’t stop taking topiramate without first consulting a medical specialist.
Topiramate can be purchased as tablets, a liquid oral solution, capsules that can be ingested whole or sprinkled on soft food, or as a combination of all three.
Topiramate is sold under the trade name Topamax.
Previous evaluations of topiramate and hazards in pregnancy
In January 2021, we released updated safety recommendations in Drug Safety Update with patient advice and a Public Assessment Report in response to a review by the Commission on Human Medicines into the safety of antiepileptic medicines during pregnancy, including topiramate.
Pregnancy topiramate use is connected to an increased risk of birth abnormalities, as well as an increased risk of low birth weight and small-for-gestational-age babies (fetal growth restriction).
The purpose of this review
The Commission on Human Medicines is consulted by the Medicines and Healthcare products Regulatory Agency (MHRA) when conducting routine reviews of the safety of pharmaceuticals.
This safety evaluation concentrates on the regulatory environment in the UK because the MHRA is in charge of the safety, effectiveness, and quality of pharmaceuticals.
The review’s scope is as follows:
To assess data on potential risks related to the use of topiramate during pregnancy from all Marketing Authorization Holders and available sources, including relevant stakeholders (patients, patient representatives, healthcare professionals, healthcare organisations, researchers, charity and patient organisations).
To determine whether more regulatory action is necessary to reduce risk and ensure risk awareness.
Should take into account how the available data will affect how topiramate’s risks and benefits are balanced in this assessment.
Pondering what other studies might be conducted to clarify the long-term effects of topiramate use on youngsters.
To provide suggestions to the Commission on Human Medicines that will help topiramate’s benefits and hazards be better balanced, to increase knowledge of those risks, and to encourage more study to assess those risks.
Following the conclusion of this safety evaluation, a report detailing the CHM’s findings and suggestions will be posted on this website and given to those who have indicated a desire to be notified.
The MHRA will go forward with the recommendations and, where appropriate, amend the review deadlines after the CHM has given the review its due consideration.
Please register your information with MHRACustomerServices@mhra.gov.uk if you would want to receive notifications regarding this safety review.
These details will only be used to let you know about this review.
As chances to participate in the review present themselves, information about them will be posted on this website and alerts will be emailed to people who have indicated they want to receive them.
Suggestion for patients
Patients are encouraged to talk to their doctor before stopping topiramate.
Talk to your doctor right away if you are taking topiramate for migraines or epilepsy and are considering becoming pregnant.
There are pregnancy-safe medications that you can use.
Consult our information on epilepsy medications and pregnancy for more details, such as the fact that levetiracetam, sold under the brand name Keppra, and lamotrigine, sold under the brand name Lamictal, are safer for the unborn child when taken during pregnancy because they reduce the risk of physical birth defects compared to the general population.
counsel for medical professionals
Continue to inform them of the recognised dangers of Topiramate use during pregnancy.
For a reminder of the most recent recommendations, refer to the July 2022 article in the MHRA’s Drug Safety Update.
Be sure to properly explain the hazards and the requirement to use extremely effective contraception throughout Topiramate treatment to the patient before initiating Topiramate in a woman who is or may become pregnant.
Topiramate should not be prescribed for migraine prevention during pregnancy.
Patients with epilepsy who are expecting should consult a specialist.
Reporting Topiramate side effects that you suspect exist:
Using information from a variety of sources, such as the Yellow Card programme, we regularly check the safety of medications in the UK.
We invite you to file a report if you think you may have encountered a topiramate adverse effect.
Anyone in the UK is able to report something to the Yellow Card programme.