Norman Lamb, MP for North Norfolk, has tabled a parliamentary motion calling for urgent action to ensure that women are properly informed of the risks of a drug which can cause severe harm to an unborn child.
Valproate is used for treating epilepsy and bipolar disorder – but has long been known to carry an increased risk of birth defects and developmental disorders in babies when taken by pregnant women. These can include spina bifida, malformations of the face, skull, limbs and organs, lower intelligence, poor speech and language skills, and memory problems.
Following a Europe-wide review, which came about following pressure from Norman Lamb and campaigners during his time as Health Minister, the Medicines and Healthcare Products Regulatory Agency (MHRA) has developed a Toolkit to ensure that women who are being prescribed valproate medicines are better informed about the risks of the drug during pregnancy. The Toolkit includes clearer warning labels on valproate packaging, information booklets for women, and a checklist to ensure that the risks have been properly discussed with the prescribing clinician.
Although the Government says that the Toolkit should have been issued by the MHRA and the manufacturer in February 2016, there have been reports that many clinicians and pharmacies have not received these essential resources – meaning that women across the country remain at risk of taking the medicine without being fully aware of its dangers.
The motion tabled by Norman Lamb calls on the MHRA, UK Government, and NHS England to intervene urgently to ensure that the Valproate Toolkit is received and properly utilised by clinicians and pharmacists nationwide.
Norman Lamb said: “It’s incredibly worrying that this crucial information Toolkit isn’t getting through to women as it should. Valproate can cause severe harm to an unborn child, and the decision to use the medicine should only be made when a woman is fully informed of its risks.
“These risks have been known by regulators for decades. Now that this Toolkit has finally been developed, the Government, MHRA and NHS England must waste absolutely no time in getting to the root of this problem. There has to be accountability.”
Janet Williams and Emma Murphy from IN-FACT (The Independent Fetal Anti Convulsant Trust), which has campaigned for better communication of the risks of using valproate in pregnancy, said:
“IN-FACT worked closely with the MHRA to agree and disseminate the Valproate Toolkit. But because the MHRA has only sent the toolkit to pharmacies and surgeries that subscribe to its alerts system, it seems that its distribution has been left largely in the hands of the drugs company.
“This has caused system failure with this vital information not reaching women of child-bearing age, and therefore around 30,000 women prescribed valproate unable to make that all-important informed choice.”
EDM 83: VALPROATE TOOLKIT
That this House notes with concern that the medicine valproate, which is used for the treatment of epilepsy and bipolar disorder, can seriously harm an unborn child when taken during pregnancy, including increased risk of malformations and developmental disorders; welcomes the development of a valproate toolkit to aid communication of the risks of valproate in pregnancy, including a warning on package labelling, a checklist for discussion between prescribers and patients, a reminder card and information booklet for women, and a booklet for healthcare professionals; further notes that the toolkit was disseminated by the Medicines and Healthcare products Regulatory Agency (MHRA) and the valproate manufacturer, Sanofi, in February 2016; expresses concern at reports that many pharmacists and clinicians have not received the toolkit, potentially leaving many women ill-informed of the severe risks of the medicine; and urgently calls on the Government, the MHRA and NHS England to work together to ensure that the toolkit is effectively disseminated and utilised across the country so that all women being prescribed valproate are fully informed of the risks to an unborn child.