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Sanofi indicted in France over epilepsy drug birth defects

Faces allegations over a failure to warn women about risks associated with drug

Sanofi

Sanofi has revealed that it has been indicted in France in connection with an investigation over birth defects linked to one of its epilepsy drugs.

The probe centres on allegations that the French drugmaker failed to provide sufficient warnings to women prescribed Depakine (sodium valproate) – also sold as Depakote and Epilim – about the risk of congenital defects and neurological harm to the foetus if the drug was taken during pregnancy.

Sanofi has been under scrutiny for its activities in relation to Depakine since 2016, according to a Les Echos report, which cites Sanofi as saying the indictment will allow it to defend its actions and “prove it has always complied with its to duty to inform and been transparent”.

Despite its maturity, the drug has been one of Sanofi’s reliable mid-size products, bringing in around €450m in sales from use in epilepsy and bipolar disorder in 2018.

Sanofi is also facing a class-action lawsuit in France in connection with birth defects that plaintiffs claim are a result of exposure to Depakine, involving some 2,000 families represented by umbrella organisation APESAC, but has so far been adamant it will not take part in any state-backed compensation scheme.

The safety of Depakine and other sodium valproate-containing products has been under scrutiny since a European assessment of the benefit/risk ratio of sodium valproate medicines in women of childbearing age, which was carried out in December 2014.

That in turn led to France’s National Agency for the Safety of Medicines and Health Products (ANSM) laying down new rules for prescribing these drugs to doctors in May 2015.

The following year, France’s social affairs inspection agency IGAS took issue with what it said was a slow response by the health authorities and Sanofi to updating the labelling of sodium valproate to reflect the new findings on its safety profile in pregnancy.

Sanofi insists the data sheet for the drug made reference to the risk of congenital malformations from the 1980s, and also claims it asked the regulator for approval to include warnings in patient information, a request which was refused.

IGAS has estimated that between 2006 and 2014, somewhere between 425 and 450 babies suffered congenital birth defects or were stillborn after exposure to Depakine, according to Les Echos.

Meanwhile, ANSM has just published revised figures on the exposure of pregnant women to valproate drugs, saying it has decreased 80% between 2013 and 2019, from 1,044 pregnancies to 224. At the same time, the rate of terminations among pregnancies in exposed women has been rising.

The use of valproate drugs in women of childbearing age has also fallen by 55% over the same period, says the regulator.

“The measures to reduce exposure to valproate…are being maintained and will soon be reinforced via the integration of the patient card inside or on the outside of the medicine box, the affixing of a QR code on these boxes and on the instructions leading to a dedicated information page on the ANSM website,” it adds.

Article by
Phil Taylor

5th February 2020

From: Regulatory

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