Norman to lead House of Commons debate on Valproate scandal

Norman Lamb will lead a debate in the House of Commons next Thursday (19th October) calling on the Government to provide financial assistance and a care plan for the thousands of families affected by the Valproate scandal.

It is estimated that up to 20,000 children have been born with disabilities and congenital abnormalities as a result of women being unaware of the risks of taking the drug, which is used to treat epilepsy, during pregnancy. These can include spina bifida, memory problems, poor speech and language skills, and lower intellectual abilities.

Health authorities were aware of the serious adverse effects of valproate in the early 1970s, but decided not to include warnings on package inserts as it was thought that this “could give rise to fruitless anxiety”.  Thousands of pregnant women have continued to take the medicine in the four decades since, unaware of the risks that it presents to the unborn child when taken in pregnancy.

In February 2016, the Medicines and Healthcare Products Regulatory Agency (MHRA) launched the ‘Valproate Toolkit’, a collection of materials designed to ensure that the risks associated with valproate are routinely and effectively communicated to women who are being prescribed the medicine.

However, the distribution of these materials has been deeply flawed, with a recent survey by three national epilepsy charities showing that 68% of women had not received the new safety warnings.

Norman Lamb, Chair of the All Party Parliamentary Group (APPG) on Valproate and Other Anti-Epileptic Drugs in Pregnancy, has been campaigning for the Government, NHS England and the MHRA to take urgent action to ensure that all women are fully aware of the risks of taking Valproate in pregnancy.  The Group is also urging ministers to provide appropriate financial assistance to families affected by ‘Fetal Anti-Convulsant Syndrome’, after the French Parliament voted to create a €10 million nationwide compensation fund in November 2016.

The three-hour debate has been co-sponsored by Labour MP Paul Flynn and the Conservatives’ Graham Brady, who are also members of the APPG.

Commenting after securing the debate, Norman Lamb said:

“This is one of the most severe health scandals in history. It bears a number of striking similarities to the thalidomide tragedy.

“For more 40 years, women with epilepsy have been taking the drug with no real idea about the risk to their unborn child. Health regulators decided at the time to keep these hidden from patients, and there has been ongoing complacency about alerting women to the potential risk. The consequences for thousands of children and their families have been life-changing.

“A new toolkit was launched last year to ensure that warnings are properly communicated, but recent surveys have shown that a worrying number of women are still not receiving the information they need to make an informed choice about whether to take the medicine.

“It is critically important that the Government acts to ensure that the warnings are getting through. I am also strongly of the view that there should be financial assistance for people who have suffered as a result of this extraordinary failure.  That is what I will be calling for on Thursday.  I hope that the debate will highlight cross-party strength of feeling on the issue, and persuade the government to act. The moral imperative to do so is overwhelming."


Additional Information

Further information about the Valproate Toolkit can be found on the official website here.

The role of medical experts and regulators in hiding the risks to pregnant women recently featured prominently in The Guardian, The Telegraph, The Times, The Daily Mail, Sky News, and BBC News.

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