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Danger of taking the Epilepsy Drug during Pregnancy

Danger of taking the Epilepsy Drug during Pregnancy

by Yash Saboo September 26 2017, 4:00 pm Estimated Reading Time: 2 mins, 44 secs

Survey says that the warnings about the hazardous nature of Epilepsy drugs are not reaching women. Almost 70% of women surveyed had not received new safety warnings about the dangers of taking the drug during pregnancy. Sodium valproate, known as Epilim, has side effects such as severe hair loss and skin rash. But most importantly it carries a 10% risk of physical abnormalities in unborn babies. About 20,000 children have been harmed by valproate medicines in the UK since the 1970s. Now the drug is under constant review.

Babies exposed to the drug in the womb have a 40% risk of developing autism, low IQ, and learning disabilities. Three charities - Epilepsy Society, Epilepsy Action, and Young Epilepsy commissioned a survey of 2000 women and girls.

475 were currently taking the drug, of which 68% of them said they did not receive any warnings and some women were not aware of the fact these drugs are harmful at all. 21% said that a healthcare professional took the initiative of making them aware of the harm it caused during pregnancy.

A toolkit called the Valprorate Toolkit created after the European Medicines Agency told all national watchdogs to improve information for patients. Launched in February 2016 it included printed warnings for patients in GPs' surgeries, hospitals, and pharmacies, containing up-to-date information on the risks for neuro-developmental disorders in children of women taking the drug.

The drugs have been prescribed since 1970 but its only until 2016 that the information has been put on packets. Its chief executive Clare Pelham, said the survey showed that the number of women who had never had a conversation with their doctor about the risks of the drug was ‘stubbornly high, hovering around 20%’. She added: “Thousands of babies have been born with disabilities whose mothers were totally unaware of the risks - and will continue to be if nothing is done”.

GPs issuing repeat prescriptions to women for more than 12 months without face-to-face consultations with them will be stopped by The Epilepsy Society. The Medicines & Healthcare Products Regulatory Agency (MHRA) in the UK says valproate had been, ‘kept under constant review and as new data have become available, the warnings have been updated’.

They said, "the results of the survey are important in helping us understand the effectiveness of the measures taken to date in the UK. We want to encourage all women to have access to the valproate toolkit materials that we made available in February 2016. We constantly monitor the safe use of valproate and support this latest review by the European Medicines Agency on the use in pregnancy and women of childbearing age."

The results of the survey will be presented next week to the European Medicines Agency, which will examine whether current warnings are adequate. Prof Helen Stokes-Lampard, chair of the Royal College of GPs, said: "Any incidences in which valproate has been prescribed for pregnant women are a cause for concern. Patients should never hesitate to raise any concerns they have about valproate, or any other medication, with their GP or other health professional."

"We call on all agencies to redouble efforts to ensure that the most up-to-date warnings are widely distributed to all healthcare professionals and patients - and the RCGP will continue to play our part in ensuring we achieve this.”




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