Other safety alerts
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| The United Kingdom: Valproate (Belvo, Convulex, Depakote, Dyzantil, Epilim, Epilim Chrono or Chronosphere, Episenta, Epival, and Syonell): review by two specialists is required for initiating valproate but not for male patients already taking valproate |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that review by two specialists remains in place for patients initiating valproate under 55 years of age but the Commission on Human Medicines (CHM) has advised that it will not be required for men (or males) currently taking valproate. Three infographics have been developed to provide clarity regarding valproate prescribing.
Valproate (as sodium valproate, valproic acid or valproate semisodium) is authorised for the treatment of epilepsy and bipolar disorder. Valproate is known to have potential risks of major congenital malformations or neurodevelopmental disorders in children when mothers take valproate during pregnancy. More recently, the risk of a range of neurodevelopmental disorders in children born to fathers taking valproate compared to other antiseizures medicines has been described.
Studies have shown that the use of valproate during pregnancy is associated with risks of physical defects, in around 1 in 9 babies exposed, and neurodevelopmental disorders, in around 3-4 in 10 babies when mothers use valproate in pregnancy. There is a much lower potential risk of neurodevelopmental disorders, in around 5 in 100 babies when fathers take valproate in the 3 months before conception. Additional reproductive risks of valproate in male patients include infertility in humans and evidence of testicular toxicity in animals.
In 2022, the CHM reviewed the latest data on the reproductive risks with valproate. Their advice was communicated in Drug Safety Update December 2022. The CHM formed an implementation group to advise on the safe introduction of the new measures into clinical practice. The measures were applied first to all new patients under 55 years old and women of childbearing potential already under specialist review. The National Patient Safety Alert on 28 November 2023 and Drug Safety Update January 2024 provided further advice on the implementation of these requirements.
No requirement for specialist review of men currently taking valproate was introduced at this time unless the male patient was planning to father a child. The CHM recommended that any further measures should consider advice from healthcare professionals and patients developed in light of experience with the initial phase.
Advice for Healthcare Professionals:
- Review by two specialists remains in place for all patients initiating valproate under 55 years of age but the CHM has advised that it will not be required for men (or males) currently taking valproate. Given the recent recommendations in Drug Safety Update September 2024, the CHM advised that there is already sufficient risk minimisation in place for this patient group but that this position should be kept under review. In addition to the Drug Safety Update September 2024, further information on the reproductive risks for males can be found in a Public Assessment Report published in November 2023. Any patient wishing to change their medication should be referred to a specialist. The information considered by CHM and the advice issued is presented in a Public Assessment Report.
- Three infographics have been produced to clarify in which situations review by two specialists may be required:
(i) for female patients under 55 years old
(ii) for male patients under 55 years old
(iii) for male and female patients 55 years and older
- A list of who might qualify as a specialist can be found at Valproate safety measures
For details of the above advice, plese refer to the website in MHRA.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-safety-update/valproate-belvo-convulex-depakote-dyzantil-epilim-epilim-chrono-or-chronosphere-episenta-epival-and-syonellv-review-by-two-specialists-is-required-for-initiating-valproate-but-not-for-male-patients-already-taking-valproate
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, of which 2 cases were reported as congenital malformations in neonates exposed to valproate during pregnancy. Related news on potential risks to children when mothers taking valproate during pregnancy or children born to fathers taking valproate, and measures to reduce the reproductive risks of valproate was previously issued by various overseas drug regulatory authorities, and was posted on the Drug Office website since 2 Jul 2011, with the latest update posted on 6 Sep 2024. Letters to inform local healthcare professionals were issued by the DH on 4 Jul 2011, 7 May 2013, 13 Oct 2014, 12 Feb 2018, 13 Dec 2022 and 22 Mar 2023.
The Registration Committee of the Pharmacy and Poisons Board discussed the matter related to the risks in pregnancy associated with the use of valproate in Sep 2011, Dec 2014, Dec 2018 and Jun 2019. Currently, the package insert or sales pack label of locally registered valproate-containing products should include safety information on the risk of malformations and impaired cognitive development in children exposed to valproate during pregnancy, and contraindications, e.g. in women of childbearing potential unless pregnancy preventive measures have been implemented, etc. The certificate holders of locally registered valproate-containing products are also required to implement risk minimisation measures, e.g. patient information leaflet should be provided, etc.
As previously reported, the matter will be further discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/Friday, Feb 14, 2025
Issued at HKT 16:00
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