Sanofi
will accept epilepsy drug blame if court rules that way
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[October 28, 2016]
By Noëlle Mennella
PARIS (Reuters) - Sanofi will accept any
blame attributed to it by a court over the harmful effects of its
epilepsy treatment Depakine on unborn babies in a case that also
involves health authorities and practitioners, the French drug company's
scientific affairs director said.
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The company has so far made no financial provisions for compensating
victims and families affected by stillbirth, malformations and slow
neurological development, believing that it has always fulfilled its
obligations with regard to transparency, Pascal Michon told Reuters
in an interview.
"We expect the justice system to do its work," he said. "Only the
courts can establish the exact responsibilities in this complex
case. If we are found to be responsible then we will assume that
responsibility just as we always have."
Depakine is a branded form of the medication known as valproate
which treats epilepsy and bipolar disorder. It has been on the
market since 1967.
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Evidence grew toward the end of the 20th century that the drug could
cause deformities in unborn children, but it was not until 2014 that
the European Medicines Agency decreed it should be prescribed only
when other treatments had failed, and only with accompanying
evidence that patients had been informed of the risks during
pregnancy.
"We know with hindsight the neurodevelopmental risks linked to
valproate. The risks are known today and they were not known in the
1990s," Michon said.
In a report published in February, French social affairs inspection
agency IGAS criticized the slow response of French health
authorities and Sanofi with regard to the risks related to Depakine
and its derivatives.
IGAS estimates that between 2006, when the medicine started carrying
a health warning, and 2014, when the rules were further tightened,
some 425 to 450 babies suffered congenital birth defects or were
still-born following exposure to the drug.
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The French parliament is to vote later this year on a compensation
mechanism for victims of the drug's side effects and a judicial
investigation was launched last year after a group of families
lodged a legal complaint.
French Health Minister Marisol Touraine has said the government will
approach other parties to pay their dues should the courts establish
blame.
Depakine is also prescribed under other brand names and in more than
100 other countries. It went off patent in 1998.
Michon, a qualified doctor, would not offer any estimate of the
potential cost to the company.
Depakine generated some 206 million euros ($225 million) of sales
for Sanofi in the first half of 2016 out of total sales of 15.9
billion euros.
(This version of the story has been refiled to correct headline and
first paragraph, which incorrectly said Sanofi wants blame to be
shared)
(Writing by Andrew Callus; Editing by David Holmes)
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