Warnings about the risk posed by taking the epilepsy drug sodium valproate during pregnancy are note reaching patients, a charity survey has indicated.
Almost 70% of women surveyed said they had not received new safety warnings about the dangers of sodium valproate (Epilim), which carries a 10% risk of physical abnormalities in unborn babies.
Babies exposed to the drug in the womb also have a 40% risk of developing autism, low IQ and learning disabilities. Since its introduction in the 1970s, around 20,000 children are estimated to have been harmed by the drug in the UK.
A new toolkit was launched early in 2016, after the European Medicines Agency told bodies, including the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), to improve information for patients.
- New toolkit on risks of valproate during pregnancy
- Nurses ‘must have time’ to discuss valproate risks
- Reminder on valproate risk for pregnant women
The toolkit included printed patient warnings in GP surgeries, hospitals and pharmacies, with up-to-date information on the risks of neuro-developmental disorders associated wih taking the drug.
Of the 475 currently taking the drug, 68% said they had not received the new warnings known as the valproate toolkit.
The survey also showed that 18% of women taking valproate did not know it could “negatively affect the development and/or physical health of children born to women taking this medication”.
In addition, 21% said they had not had a discussion initiated by a healthcare professional about the risks of taking the drug during pregnancy.
The data was collected between 17 August and 20 September 2017. The survey, which is currently running, has been held in conjunction with the MHRA.
The Epilepsy Society is now calling on the government to make immediate changes to prevent repeat prescriptions to women for more than 12 months without face-to-face consultations.
It also wants routine checks at family planning clinics to include discussions about the risks of sodium valproate in pregnancy.
The results of the survey will be presented next week to the European Medicines Agency, which will examine whether current warnings are strong enough
Women whose children have been harmed by the epilepsy drug sodium valproate will also give evidence to the European-wide safety review.
Meanwhile, the UK’s MHRA said valproate had been “kept under constant review” and, as new data became available, it had update its warnings.
The Royal College of GPs called on all agencies to “redouble efforts” to ensure that the most up to date warnings were widely distributed to all healthcare professionals and their patients.
The Association of British Neurologists added that it was working with the MHRA to ensure young women prescribed valproate were fully aware of the risks of becoming pregnant while taking it.
“Patient safety and welfare is a primary concern for everyone in the pharmaceutical industry”
Speaking ahead of the EMA hearing next week, Dr Virginia Acha, executive director of research, medical and innovation at the Association of the British Pharmaceutical Industry, said: “Patient safety and welfare is a primary concern for everyone in the pharmaceutical industry and we express our deepest sympathy to those individuals who suffer from malformations or developmental disorders that may be related to their mother’s treatment with anti-epileptic medicines.
“For each and every patient, it is absolutely critical that the risks and benefits of medicines are identified, considered and continually monitored,” she said. “This is certainly the case for patients suffering from epilepsy where despite the availability of several effective treatments, used to help people live active lives, thousands of British patients still have no effective control.
She added: “Patients and their doctors should continue to refer to the MHRA’s excellent toolkit and guidance that ensures everyone is better informed about the risks of taking valproate medicines during pregnancy.”