Epilim® (Sodium Valproate): Important new restrictions on use

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Description

Children exposed in utero to valproate are at risk of serious developmental disorders (in up to 30-40% of cases) and congenital malformations (in approximately 10% of cases). Previously in 2015, the warnings and restrictions on the use of valproate medicines in women and girls were strengthened, to minimise the risk of malformations and developmental problems in babies exposed to valproate in the womb.

Recently, a Direct Healthcare Professional Communication (DHPC) letter has been issued by Sanofi-Aventis (Malaysia) Sdn. Bhd. in agreement with the NPRA to highlight new contraindications, strengthened warnings and measures to prevent valproate exposure during pregnancy.

 

New contraindications

  • In epilepsy:

- valproate is contraindicated in pregnancy unless there is no suitable alternative treatment.

- valproate is contraindicated in women of childbearing potential, unless the conditions described in the DHPC letter are fulfilled.

  • In bipolar disorder:

- valproate is contraindicated in pregnancy.

- valproate is contraindicated in women of childbearing potential, unless the conditions described in the DHPC letter are fulfilled.

 

For further information, please contact your local sales person for a copy of the DHPC.

Patients are advised not to stop taking sodium valproate without first discussing it with their doctor.

National Pharmaceutical Regulatory Agency (NPRA)
Lot 36, Jalan Universiti, 46200 Petaling Jaya, Selangor, Malaysia.
  • Email: npra@npra.gov.my
  • Phone: +603-7883 5400
  • Fax: +603-7956 2924, +603-7956 7075

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The Government of Malaysia and the National Pharmaceutical Regulatory Agency are not responsible for any loss or damage caused by the usage of any information obtained from this website.

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  • Last Modified: Wednesday 21 August 2019, 09:55:47.
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