Sodium Valproate: What Regulators Knew, and When They Warned Women

A BBC Two documentary airing on November 9 will put the epilepsy drug sodium valproate back in the spotlight, featuring two mothers who have spent years campaigning for compensation for children born with birth defects linked to the medication.

Emma Murphy and Janet Williams appear in *Mums v Big Pharma*, from the co-producers of *Mr Bates vs The Post Office*. Murphy took sodium valproate, brand name Epilim, from the age of 12 to manage her epilepsy. She realised in 2009 that her children had been affected.

The drug is linked to a range of disorders: autism, malformation of the skull, limbs, heart, kidney, urinary tract and sexual organs, as well as deafness, difficulty learning to walk and talk, and lower intellectual ability. At least 20,000 children in the UK are thought to have been affected since the 1970s.

That sodium valproate can harm babies in the womb has been known since the 1970s. The central question the documentary raises is why women were not warned sooner. A new report says government regulators were aware of the devastating effects on unborn children but did not warn women of the risks.

Murphy and Williams have spent years uncovering evidence of that gap. Their campaign asks what regulators knew, when they knew it, and why warnings did not reach the women taking the drug.

The numbers are not exact.

The documentary airs on November 9. It arrives as a news peg for a longer-running question about drug safety oversight: when evidence of harm exists, what obligation do regulators have to act on it, and how quickly?