20,000 left disabled in UK due to sodium valproate use during pregnancy

pharmafile | January 22, 2018 | News story | Medical Communications, Sales and Marketing Epilim, Sanofi, Sodium valproate, UK, pharma 

Liberal Democrat MP Norman Lamb has drawn attention to what he has called an “extraordinary scandal” in which an estimated 20,000 children in the UK have been left with disabilities due to the use of anticonvulsant sodium valproate by mothers during pregnancy in the 1970s.

The drug, better known as Sanofi’s Epilim, has been traditionally prescribed for the treatment of epilepsy and bipolar disorder, but its use during pregnancy has been found to increase the risk of autism, low IQ, learning disabilities and physical abnormalities in babies in the womb. New research also suggests these traits can be passed on through generations.

Parents affected have claimed that they were not made aware of the risks even after new safety warnings were published in 2016, and are now demanding a public inquiry and compensation. Campaigners have argued that the risks of the drug have been known for more than 40 years: “These warnings could have and should have been given in 1974,” Catherine Cox from the Fetal Anti-Convulsant Syndrome Association said last year. “However, there was a deliberate decision not to publish them.”

Lamb has called for action along similar lines to France, whose government is supporting a charity-led campaign to tackle the same problem.

The MHRA is said to be “constantly reviewing” the medication, while the Department of Health has said it expects the MHRA to take further action to inform the public on these health risks.

“Patient safety is always our priority. We want to make sure doctors give women the right information when prescribing these drugs — that’s why the medicines regulator is already reviewing how effective measures to highlight these risks have been,” a Department of Health and Social Care spokesperson said. “We expect them to take further action if they find that more can be done.”

Sanofi has defended its product, saying that while it is “aware of the challenging situations faced by families with children with conditions that may be related to their mother’s treatment with antiepileptic drugs”, it has always provided adequate warning of the dangers of the drug: “[sodium valproate] has at all times been supplied in the UK with a warning of the risk of malformations in babies”.

Matt Fellows

Related Content


Sanofi and Teva partner for development of inflammatory bowel disease treatment

Sanofi and Teva Pharmaceuticals have announced that they will collaborate for the co-development and co-commercialisation …

Regeneron and Sanofi’s sBLA for Dupixent accepted by FDA for priority review

Regeneron Pharmaceuticals and Sanofi have announced that the US Food and Drug Administration (FDA) has …

Pharmanovia acquires CNS portfolio from Sanofi

Pharmanovia has announced that it will expand its neurology portfolio with the acquisition of a …

Latest content