ADR that result in revision of patient information
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| The United Kingdom: Valproate use in men: as a precaution, men and their partners should use effective contraception |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that a retrospective observational study has indicated a possible association between valproate use by men around the time of conception and an increased risk of neurodevelopmental disorders in their children. Inform male patients who may father children of this possible increased risk and the recommendation to use effective contraception during valproate treatment and for at least 3 months after stopping valproate. No one should stop taking valproate without talking to their healthcare professional.
Information for healthcare professionals:
- Findings from a retrospective observational study, combining analyses of electronic medical records in Norway, Denmark and Sweden, indicate a possible increased risk of neurodevelopmental disorders in children born to men treated with valproate in the 3 months prior to conception, compared to those born to men treated with lamotrigine or levetiracetam.
- In the study, the cumulative risk of neurodevelopmental disorders ranged from 4.0% to 5.6% in the valproate treated group versus 2.3% to 3.2% in the composite lamotrigine/levetiracetam monotherapy treated group (pooled adjusted hazard ratio 1.50, 95% CI 1.09 to 2.07).
- This potential risk is much lower than the up to 30-40% risk of neurodevelopmental disorders in children born to mothers taking valproate during pregnancy, estimated from several studies.
- The study did not include an untreated group and background risk in this patient population is therefore unknown.
- An increased risk of neurodevelopmental disorders in children of fathers treated with valproate in the 3 months prior to conception is possible however the causal role of valproate is not confirmed. As such this advice is precautionary.
Advice for healthcare professionals:
- Inform male patients (of any age) who may father children of the possible risk at initiation of valproate or at their next regular treatment review – this counselling should be given irrespective of the indication for valproate and also after intravenous use of valproate.
- As a precaution, recommend that male patients use effective contraception (condoms, plus contraception used by the female sexual partner) throughout the valproate treatment period and for 3 months after stopping valproate, to allow for one completed sperm cycle not exposed to valproate.
- At the next regular treatment review, discuss with men on oral valproate treatment whether they are planning a family in the next year and if they are, refer to a specialist to discuss alternative treatment options.
- If a female patient reports they are pregnant or planning a pregnancy with a man on valproate (including those undergoing IVF), refer for prenatal counselling.
- Advise men not to donate sperm during valproate treatment and for 3 months after stopping valproate.
Changes will be made to the product information available online. The Patient Information Leaflet in the box and hard-copies of the updated safety and educational materials will be available in the coming months. The current patient card will be amended to include advice for male patients in addition to the measures relating to the Pregnancy Prevention Programme for women. The manufacturers of valproate will also send a letter to relevant healthcare professionals in October 2024.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-safety-update/valproate-use-in-men-as-a-precaution-men-and-their-partners-should-use-effective-contraception
In Hong Kong, there are 10 registered pharmaceutical products containing valproate. All products are prescription-only medicines. So far, the Department of Health (DH) has received 17 cases of adverse drug reaction with regard to valproate, but these cases were not related to neurodevelopmental disorders in children after paternal exposure to valproate. Related news was previously issued by Health Sciences Authority, MHRA and European Medicines Agency, and was posted on the Drug Office website since 22 Mar 2023, with the latest update posted on 27 Jan 2024. Letters to inform local healthcare professionals were issued by the DH on 22 Mar 2023. As previously reported, the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/Friday, Sep 6, 2024
Issued at HKT 17:45
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