The Medicines and Healthcare products Regulatory Agency (MHRA) has changed the licence for valproate medicines, so that they can no longer be prescribed to females of child-bearing age unless they are on the pregnancy prevention programme (PPP).
Valproate - which is available on the UK market as Epilim, Depakote and generic brands - is an effective treatment for epilepsy and bipolar disorder.
However, children born to women who take the drug during pregnancy are at significant risk of birth defects (around 10 percent) and persistent developmental disorders (up to four in 10), the regulator stressed.
Going forward, healthcare professionals wishing to prescribe valproate must ensure that female patients of child-bearing age are enrolled in the PPP, which includes the completion of a signed risk acknowledgement form when their treatment is reviewed by a specialist, at least annually.
These regulatory changes, which are desiged to protect public health, will be further supported in the upcoming months by smaller pack sizes to encourage monthly prescribing and a pictogram/warning image on valproate labeling, the MHRA noted.
In parallel, the National Institute for Health and Care Excellence (NICE) is updating its guidelines to reflect the new regulatory position.
“Patient safety is our highest priority. We are committed to making sure women and girls are aware of the very real risks of taking valproate during pregnancy. However, we also know it is vitally important women don’t stop taking valproate without first discussing it with their doctor,” noted Dr June Raine, director of MHRA’s Vigilance and Risk Management of Medicines Division.
“Our priority is always patients’ safety, so I welcome this decision to take strong actions to protect women and children,” added Health Minister Lord O’Shaughnessy. “The focus will now be on explaining these changes to GPs and clinicians so they in turn can advise patients.”
The Royal Pharmaceutical Society also welcomed the move.
“The RPS fully supports these new measures implemented today by the MHRA 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,” said president Ash Soni.
“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.”
“Despite previous interventions, we know there are still far too many women who haven’t been made aware of the potential risks of taking sodium valproate in pregnancy,” noted Simon Wigglesworth, deputy chief executive of Epilepsy Action. “It is vitally important that healthcare professionals ensure that all women with epilepsy taking sodium valproate are reviewed in line with the new guidelines.”