MHRA bans sodium valproate medications (Epilim) for women “of childbearing potential”
25th April 2018
On the 24th March 2018, The Medicines and Healthcare products Regulatory Agency (MHRA) has banned prescriptions for medicines that contain sodium valproate for women who could potentially become pregnant.
These medicines are often used to treat epilepsy and are more commonly known by their brand names, which include Epilim, Epilim Chrono, Epilim Chronosphere MR, Episenta and Epival CR. Valproic acid is prescribed under the names Convulex and Depakote. For many these medicines are the most effective form of medication for treating epilepsy.
What’s the problem with sodium valproate?
Studies have shown that medications containing sodium valproate can result in birth defects and developmental problems when taken during pregnancy. It’s not the only epilepsy medication that carries this risk, however, it’s thought that the risk with sodium valproate is much higher.
Are there any exceptions?
The ban applies to all women who are “of childbearing potential”, which means that anyone who could become pregnant will lose access to the medication. This is to prevent the chance of the medication being used should the pregnancy be undetected. In order to keep access to medications such as Epilim, the women or girls must first enrol on the Pregnancy Prevention Programme (PPP).
What is the PPP?
The programme specifies that a healthcare professional must first warn the service user of the complications that can arise should they become pregnant whilst taking Epilim or other sodium valproate medications. They must also be made aware of the need to use contraception and as a result, fill out a risk acknowledgement form.
Is there anything else?
This ban is the first of a series of regulation changes that are expected over the coming months. New measures include smaller pack sizes and more prominent warning labels and images. There will also be computer alerts for GPs to guide them when prescribing the medication.
In addition, The National Institute for Health and Care Excellence (NICE) and The European Medicines Agency (EMA) are both reviewing their guidelines on sodium valproate. Both are expected to impose stricter control over the prescription of these medications for women and girls of childbearing age and will adhere to the new regulations.
What can I do if I’m using Epilim or sodium valproate medications?
If you’re a woman of childbearing age, we would highly recommend talking to your specialist nurse or healthcare professional. Unless you enrol in PPP it’s highly likely you will need to find an alternative medication to treat your epilepsy.
At National Epilepsy Training we can help, we provide a medication review service that can help to ensure you find an effective alternative for Epilim or associated medications. Call us on 01706 373075 or email admin@nationalepilepsytraining.co.uk to speak to one of the team today.
