The Medicines and Healthcare products Regulatory Agency (MHRA) have introduced new rules prohibiting medical professionals from prescribing sodium valporate to women who are of childbearing age unless they are on a pregnancy prevention plan. Women of childbearing age who suffer from epilepsy will now be reviewed on an annual basis by a specialist.
Sodium valproate is used to treat epilepsy and bipolar disorder, but it can also be prescribed to prevent migraine headaches.
Some women who had previously been prescribed the drug during pregnancy have given birth to babies who have suffered disabilities. If a baby is exposed to the drug during pregnancy, there is a risk (around 30% - 40%) of the child being born with physical disabilities and developmental issues.
It is estimated that around 20,000 children have been affected in the UK since the drug was first introduced during the 1970s.
The new changes mean that any healthcare professional seeking to prescribe the medication must ensure that they discuss effective contraception to prevent pregnancy. They also have to discuss treatment options available and any risks in taking the medication. A GP must complete and sign a form with their patient, who must acknowledge that the risks have been discussed, and that they have fully understood them.
Packaging sizes will now be smaller so that prescriptions are reviewed on a more regular basis, and warning labels will be placed on packaging for valproate medication advising against its use during pregnancy.
