Epilepsy drug link to brain damage in 17,500 babies

The Sunday Times 3 February 2013 Lois Rogers

AN ESTIMATED 17,500 babies with mental development disorders have been born to mothers using the anti-epilepsy drug Epilim in pregnancy, according to a new study.

It is estimated that more than one in three babies born to mothers using Epilim since its launch in 1973, have suffered debilitating autism and other behavioural and learning difficulties. Many will require lifelong institutional care and never be able to lead independent lives.

Campaigners are warning of a disaster more widespread than the thalidomide scandal in the 1960s, which led to 2,000 babies being born with missing limbs.

Families of the 600 affected children so far identified will meet Andy Burnham, the shadow health minister, at the House of Commons on Tuesday, to enlist support for a campaign to press Epilim’s manufacturer, Sanofi, to take the drug off the market. They also want the company to pay towards the care of affected children.

It has long been known that Epilim could increase the risk of physical defects, and Sanofi says it has done everything it can to warn patients.

“Because of the well-known risk of birth defects, for a number of years [Epilim] has not been recommended as a first-choice agent for women with epilepsy who are of child-bearing potential,” a Sanofi spokesman said.

Although the first study linking Epilim with an increased risk of birth defects appeared 30 years ago, the scale of the risk of mental disorders has emerged only in a study published this week in the Journal of Neurology, Neurosurgery and Psychiatry, which shows the drug increases this risk at least 10-fold.

The new study tracked the development, over six years, of 243 babies born between 2000 and 2004 to mothers with epilepsy who were either taking a variety of different drugs to control their condition, or none at all.

Their progress was compared with 285 babies born to non-epileptics at the same time in the same area. Epilim use emerged as a key link with subsequent mental development disorders.

Rebecca Bromley, a senior neuropsychologist at Liverpool University, who led the project, estimates that 35% of the 48,000-50,000 babies born to mothers who have taken the drug have been affected.

“Since the thalidomide scandal, the focus has always been on drugs in pregnancy which might cause physical rather than mental defects,” she said.

Emma Murphy, 32, from Manchester, has five children all apparently affected by Epilim exposure. The learning disabilities and autism suffered by Chloe, 9, Lauren, 8, Luke, 7, Erin, 5, and Kian, 3, were diagnosed only after the birth of Erin.

Murphy, who has since become a leading campaigner in the Independent Fetal Anti-Convulsant Trust (In-Fact) set up three months ago, says at no stage was she advised that Epilim could be to blame for her babies’ problems.

“I had total belief in the doctors. Knowing about drugs is their job,” she said. “I only asked to be swapped onto a different drug when I happened to see a television programme about Epilim, but by then it was too late.”

Although GPs are advised they should not prescribe Epilim to epileptic women of child-bearing age except in exceptional circumstances, Peter Turnpenny, a consultant geneticist at the Peninsular Medical School in Exeter who is working with In-Fact, says he continues to see affected babies.

“There are still children being born with brain damage that could be avoided,” he said.