Advertisement

Valproate risk 'hidden' from pregnant women for decades

The dangers of pregnant women using epilepsy drug valproate have been kept from patients for decades, according to documents uncovered from The National Archives.

Two years ago, a new Europe-wide alert warned that the drug caused disabilities in 40% of the babies of mothers who used valproate.

But campaigners have discovered documents, seen by Sky News, suggesting that in July 1973 regulators decided not to warn patients directly for fear it "could give rise to fruitless anxiety".

:: Valproate behind thousands of birth defects - study

At the time health professionals were told: "This compound has been shown to be teratogenic in animals, meaning it could harm the human foetus."

But the Committee on Safety of Medicines, a precursor to the MHRA (Medicines & Healthcare products Regulatory Agency), instructed the same alert should "not (go) on the package inserts, so that there would be no danger of patients themselves seeing it".

Estimates of the number of babies born with disabilities by women who used the drug range from 7,000-20,000.

Recent research by epilepsy charities found that one in every six users remain unaware of the risks.

Campaigners are passing their findings to the European Medicines Agency and are calling on Health Secretary Jeremy Hunt to make an urgent public warning and ensure all women and girls taking the drug have annual consultations about the risks associated with pregnancy.

Valproate syndrome sufferer, Branwen Mann, 21, will tell the hearing of the horrendous side effects she suffers after her mother, Deborah, who took valproate from the age of 14, was prescribed a higher than normal dose during pregnancy.

Ms Mann told Sky News: "I've developed issues with my brain, I've got these blanking spells that I know is not epilepsy, I suffer from migraines, I've been told I could die any time soon."

Janet Williams, chief executive of In-Fact, a support group for victims of the drug, found the documents in The National Archives.

She told Sky News: "We want to make sure that all women get the informed choice and it is made mandatory that doctors must warn women pre-pregnancy.

"The documents show that the MHRA's predecessors have know about this since 1973 - and chose not to inform the patients who were prescribed it.

"I'm appalled - it's astonishing how they can carry on knowing children are being harmed by this drug and refuse to do anything about it."

Mrs Williams was encouraged to seek out the documents after meeting with alleged victims of the drug Primodos, who also believe they were let down by the same regulator.

The licence issued in 1974 for Epilim, a trade name for sodium valproate, insisted that doctors and pharmacists should use it only in severe cases of epilepsy or where there was no alternative.

About 28,000 women aged 14-45 receive a prescription for valproate in the UK in a six-month period, with about 450 children born to these women a year.

A MHRA spokesperson said: "At that time, it would have been for the doctor to decide how much information a patient was given about their medicine.

"This attitude to provision of information to patients would not have been unusual at that time, particularly in relation to lifesaving medicines such as anticonvulsants, as there was a concern that information about side effects may have caused people to stop treatment."