Families with children who have been harmed by the epilepsy drug sodium valproate are demanding a public inquiry and compensation, saying they have been left with no help.
They voiced their anger outside a London hearing that is assessing if warnings for patients are adequate.
It is thought about 20,000 children have been left with disabilities by valproate in the UK since the 1970s.
Mum Emma Friedmann says she wasn’t fully informed of the risks.
Her son, Andrew, 18, has severe neurological damage, autism and other problems including hearing and sight problems. Emma was taking the drug when she got pregnant and carried on using it.
“I wasn’t properly told about all the risks,” says the 46-year-old from Leicester. “Andrew now needs full-time care, 24/7. Families like me need justice. We want a public inquiry and compensation.”
Carol Lapidge, 50, from London, whose daughter, Nicola, 31, has learning difficulties, says: “The care has not been there. I’ve had to fight for physiotherapy, speech and language therapy and occupational therapy. There has not been enough help for Nicola.”
Susan Cole, 53, from London, whose daughter Hannah, 17, has learning difficulties, says: “Some of the stories are horrific. Women have been left with nothing. The dads have left, they have no money and have been unable to work.
“There are also the miscarriages and stillbirths. We don’t know how many of them there were. But there’s been no help and no investigation into what went wrong.”
The drug, known as Epilim, is used to control seizures.
It carries a 10% risk of physical abnormalities and a 40% risk of autism, low IQ and learning disabilities.
Valproate is an effective treatment for epilepsy, bipolar disorders and migraine – and doctors prescribe it because it is the best option for some women.
Instructions for doctors – and, more recently, patient leaflets – say valproate should not be used during pregnancy unless there is no safer alternative and only after a careful discussion of the risks.
Sodium valproate has been prescribed since the 1970s, but it was only last year that additional warnings were put on the outside of packets under a new regulatory system.
The European Medicines Agency review in London will hear testimonies from families, experts and the drug’s makers Sanofi.
Sanofi has said it will review the data on the risk-minimisation measures currently in place.
In an earlier statement it said: “Sanofi will reinforce the fact that sodium valproate is an important molecule that epileptic women continue to rely on, even today, to control seizures, to avoid a potentially fatal seizure during their lifetime, including during pregnancy.”
Medicines watchdog the MHRA says the decision to use any medicine in pregnancy requires a careful evaluation of the benefits and risks to both the woman and to her unborn child.
It says that the safety of valproate in pregnancy has been kept under constant review, and as new data have become available, the warnings have been updated.
In France, 1,200 families are preparing to sue Sanofi, accusing it of failing to sufficiently inform women of the risks.
The French government is supporting the legal action and has put aside about £9m to compensate the families.
In 2010, families in England and Wales had to abandon a court case when their legal aid was withdrawn three weeks before the case was due to begin.
They signed letters promising never to sue again and, in return, were not billed for Sanofi’s multi-million pound legal costs.