A Sanofi spokesman said a decision to use valproate in women of “child-bearing potential” should only be taken after a very careful evaluation between the patient and her treating physician.
“The appropriate treatment of epilepsy before and during pregnancy is highly complex, and uncontrolled seizures during pregnancy may pose substantial risks for the mother and the unborn child,” he said.
“Because of the well-known risk of birth defects, for a number of years valproate has not been recommended as a first-choice agent for women with epilepsy who are of child-bearing potential.
“As recommended by the manufacturer, women of child-bearing potential should be informed of the risks and benefits of the use of valproate during pregnancy.
“It is important to stress that stopping any anti-epileptic medications suddenly can lead to a recurrence of seizures which may be fatal.
“Therefore, Sanofi, in accordance with expert advice and the established medical opinion, urges patients to not make sudden changes to their treatment without first discussing them with their treating physician.”
In January 2014 Health Minister Jeremy Hunt, against expert advice from the British Medical Association (BMA) Epilepsy Action and Epilepsy Society and also against lawful requirements and consultation withdrew the Quality Outcome Framework (QOF), which went some way to ensuring some of Sanofi’s admitted guidelines and requirements for safe use of Epilim were adhered to.
IS THIS PROTECTING THE 500 BABIES PER YEAR BORN WITH FACS OR THE APPROX £400 MILLION PROFITS ??
Currently everything Sanofi say should happen for safe use, doesn’t happen and there is nobody to ensure that it should!!!!!