The Medicines and Healthcare products Regulatory Agency (MHRA) has today changed the licence for valproate medicines in the UK.
Sodium valproate must no longer be prescribed to women or girls of childbearing potential unless they are on the pregnancy prevention programme (PPP).
Sodium valproate is used to treat epilepsy. It is often also prescribed under the brand names Epilim, Epilim Chrono, Epilim Chronosphere MR, Episenta and Epival CR. Valproic acid is prescribed under the brand names Convulex and Depakote. For some people it might be the most effective epilepsy medicine.
But there is a risk of birth defects and developmental problems in babies born to mothers taking the medicine during pregnancy. Other epilepsy medicines carry some risk of these complications, but the risks with sodium valproate are higher.
The changes made by the MHRA mean that healthcare professionals prescribing valproate to women or girls must make sure they are enrolled in the PPP.
As part of the PPP, the prescriber must make sure the woman or girl understands the risk if she became pregnant while taking the medicine. They must also understand the need to take contraception while on the medicine, and be referred to contraception services if needed. A risk acknowledgement form must also be completed and signed when the medicine is renewed, at least once a year.
The MHRA said that women and girls taking valproate at the moment should speak to their doctor to arrange a medicine review. The agency stressed that they should not stop taking their medicine without medical advice.
Further changes are expected to come in in the next few months. These include smaller pack sizes to encourage monthly prescriptions, and a warning image on the box. Computer alerts for GPs will also be put in place to help change the way they prescribe these medicines.
The National Institute for Health and Care Excellence (NICE) is amending its guidelines for epilepsy. Where valproate is mentioned, it will reflect the new regulations.
The European Medicines Agency (EMA) is also reviewing safety around valproate use in women of childbearing age. Stricter safety measures have been recommended by the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC). Medicines regulatory body CMDh backed these measures in April. The final decision will be made by the European Commission in the next few months. This will be legally binding across the EU.
Simon Wigglesworth, deputy chief executive of Epilepsy Action, said: “We welcome the revised measures which reflect the seriousness of the risks to the unborn children of women with epilepsy during pregnancy. It is vitally important that healthcare professionals ensure that all women with epilepsy taking sodium valproate are reviewed in line with the new guidelines.”
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New measures to avoid valproate exposure of babies during pregnancy have been backed by medicines regulatory body CMDh.