Other safety alerts
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| European Union: PRAC starts review of topiramate use in pregnancy and women of childbearing potential |
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The European Medicines Agency (EMA) announces that its safety committee (PRAC) has started a review of topiramate and the risk of neurodevelopmental disorders in children whose mothers were taking topiramate during pregnancy. Topiramate is a medicine used in the EU for the treatment of epilepsy, prevention of migraine and, in some countries, in combination with phentermine for body weight reduction.
Use of topiramate in pregnant women is known to increase the risk of birth defects. Women with epilepsy who are being treated with topiramate for their seizures are advised to avoid becoming pregnant, and to consult their doctor for advice if they wish to become pregnant. Topiramate must not be used to prevent migraine or control body weight in pregnant women and in women of childbearing potential (women able to have children) who are not using highly effective birth control methods (contraception).
The review was triggered by a recent study which suggested a possible increase in the risk of neurodevelopmental disorders, in particular autism spectrum disorders and intellectual disability, in children whose mothers were taking topiramate during pregnancy.
The study was based on data from several Nordic registries (Denmark, Finland, Iceland, Norway and Sweden), and included information from more than 24,000 children exposed to at least one anti-epileptic medicine before birth. Of these children, 471 were exposed to topiramate alone, including 246 children born to mothers who had epilepsy.
The PRAC started reviewing the study results as part of a safety signal assessment in July 2022. The committee will now conduct an in-depth review of the available data on the benefits and risks of topiramate use in pregnant women and women of childbearing potential in the approved indications. The committee will look in particular at the current risk minimisation measures and consider the need for additional measures to minimise the risks of topiramate use in these women.
While the review is ongoing, topiramate should continue to be used according to the authorised product information. Women should discuss any questions or concerns about their topiramate treatment with their doctor or pharmacist. Patients should not stop antiepileptic treatment before speaking with their doctor.
Following this review, the PRAC will give its recommendation as to whether marketing authorisations of topiramate-containing products should be maintained, varied, suspended or revoked. EMA will communicate the PRAC’s recommendation once the review has concluded.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/en/news/prac-starts-review-topiramate-use-pregnancy-women-childbearing-potential
Local Situation in Hong Kong: In Hong Kong, there are 32 registered pharmaceutical products containing topiramate. All products are prescription-only medicines. So far, the Department of Health (DH) has received 4 cases of adverse drug reaction related to topiramate, but these cases were not related to neurodevelopmental disabilities in children with prenatal exposure. Related news was previously issued by EMA and Medicines and Healthcare products Regulatory Agency, and were posted on the Drug Office website on 9 Jul 2022 amd 22 Jul 2022. The DH will remain vigilant on the conclusion of the review and any safety updates issued by other overseas drug regulatory authorities for consideration of any action deemed necessary.
Ends/ Saturday, Sep 3, 2022
Issued at HKT 12:00
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