The MHRA has announced a ban on the prescribing of valproate to women and girls of childbearing age, unless they are on a pregnancy prevention programme.
The regulatory authority announced today that the license for valproate has been changed, meaning that there will be a blanket ban on the prescription of valproate to all women of childbearing potential unless they are on a specific programme to prevent pregnancy.
Royal Pharmacuetical Society (RPS) president Ash Soni said: ‘The RPS fully supports these new measures to ensure women understand the risks of taking sodium valproate during pregnancy.
‘They must get the right information from health professionals in order to make informed choices about their health and parenting options. Valproate is an effective medicine and women should never suddenly stop taking it without talking to a health professional.
‘Pharmacists are ideally placed to give information and support when providing sodium valproate and are committed to reducing harm from medicines, enabling women to make the choices that are right for them.’
GPs are advised that they must not prescribe valproate for bipolar disorder or migraine and that they must not prescribe the drug for epilepsy unless there is no other effective treatment available.
Patients must also be signed up to a pregnancy prevention programme if they are to be prescribed valproate. The programme includes signing a risk acknowledgement form, regular pregnancy tests before, during and after treatment and a review of ongoing treatment by a specialist at least annually.
The new regulatory measures will be rolled out across the NHS, with new alerts to be set up on GP computer systems to ensure that changes in prescribing behaviour are established quickly.
The MHRA also confirmed that NICE will be reviewing all of its guidelines that include valproate and begin a full update to its epilepsy guideline in light of the licensing changes.