Valproate treatment: risks and precautions
In February 2016, the Medicines and Healthcare Products Regulatory Agency (MHRA) sent out a Drug Safety Update reminding prescribers of the risks associated with prescribing valproate based medicines to female patients, such as Epilim®, Depakote® and generic non-brand equivalents. Although these risks are well known, there is concern that valproate is still prescribed without adequate information being given to the patient. Several communication aids have been developed to support the discussion with the patient.
The risk of valproate to a foetus
Children exposed to valproate in the womb are at high risk of serious developmental disorders (occurs in up to 30 to 40% of cases) and congenital malformations (approximately 10% of cases).
It is vital that female patients receive full details of the risks of treatment with valproate and specifically the potential adverse effects to the foetus. A written consent form is recommended.
- Do not prescribe valproate to girls, female adolescents, women of child-bearing age, or pregnant women unless all other treatments are ineffective
- Valproate must be started and supervised by a doctor experienced in managing epilepsy or bipolar disorder
- Review annually
- All girls and women of child-bearing age must be informed and understand:
- The risks associated with taking valproate during pregnancy
- The need to use effective contraception
- The need for regular treatment review
- The need to speak to a doctor urgently if she is planning a pregnancy or has become pregnant
Prescribers should use the checklist provided by the MHRA and document this in the notes.
The safety information and checklists for prescribers and the educational materials for patients that have been developed are available via http://tinyurl.com/ha6334z
These include a:
- Booklet for healthcare professionals
- Checklist for healthcare professionals
- Valproate patient guide
- Valproate patient card
These resources are also available direct from Sanofi by telephoning 0345 372 7101 or email UK-Medicalinformation@sanofi.com.