A battling mum has spoken of her joy after she won a major victory with government health chiefs over drug warnings which could have saved her sons from a rare disorder.
Janet Williams, 58, who has epilepsy, was prescribed the drug Epilim by her doctor when she was pregnant with her sons, Lee, 26, Philip, 24.
Valproate can cause birth defects and problems with early development of the child if it is taken during pregnancyNew warning
Both were born with Fetal Valproate Syndrome, a rare disorder which develops when a fetus is exposed to valproic acid – a key ingredient of Epilim – during pregnancy.
More than 6,300 people are estimated to have been affected by the disorder, which can cause defects, sight problems, poor memory skills, and delays in walking, as a result of mothers taking Epilim during pregnancy – despite health bosses knowing the risks since the drug’s release in 1973.
Mrs Williams, from School Lane, Pilling, , said: “It’s bigger than Thalidomide.”
She says her sons were slow in learning to walk and talk and are unlikely to ever be able to hold down a full-time job or live independently.
In a 1973 document uncovered by Mrs Williams and fellow campaigner Emma Murphy, the committee on safety of medicines stated that the evidence that Epilim was harmful to unborn babies was not sufficiently conclusive, and that warnings should be withheld from the public to prevent “fruitless anxiety”.
It was decided that, though doctors would be made aware of the health risks, written warnings would not be included in package inserts.
Mrs Williams added: “They knew full well the damage it could cause and they let thousands of pregnant women take it without knowing.”
Mrs Williams and Mrs Murphy met with representatives from the Department of Health and Medicines and Healthcare Products Regulatory Agency in a bid to have warning labels added to Epilim’s packaging – before taking up their concerns with health minister Jeremy Hunt.
With their support, it was agreed to label the drug: “Valproate can cause birth defects and problems with early development of the child if it is taken during pregnancy.”
A spokeswoman for pharmaceutical company Sanofi UK, which manufactures Epilim, said: “The product information relating to Sanofi’s valproate-containing products has at all times appropriately reflected the available scientific and medical knowledge regarding the risks associated with its use.
“This information is available to all healthcare professionals.”