Is the Medicines and Healthcare products Regulator Agency (MHRA) guidance on sodium valproate acceptable to women of childbearing age?

BACKGROUND

The UK Medicines and Healthcare products Regulatory Agency (MHRA) published guidelines restricting the use of sodium valproate in women of childbearing age unless they consented to the pregnancy prevention programme (PPP), receiving counselling by an epilepsy specialist, or meeting exclusion criteria.

METHODS

We contacted every woman of childbearing age on valproate for epilepsy in NHS Tayside (122).

RESULTS

Seventeen out of 122 (13.9%) responded to the initial invitation to attend, and 25 out of 122 (20.4%) responded to a letter sent to their GP. Twenty-five attended, 21 completed a consent form, seven switched to another drug and three attended to express dissatisfaction with the MHRA guidance. There were 53 patients identified with learning difficulties. Consent was only taken from three patients, with carers declining to sign consent because the patient was not sexually active.

CONCLUSION

Our study suggests that patients and carers do not wish to stop valproate or engage in PPP despite being made aware of MHRA guidance.