Drugmaker Sanofi charged with birth defects

Day of issue:

French prosecutors have pushed the pharmaceutical giant Sanofi for epilepsy to have birth defects associated with an epileptic drug, the company said on Monday, in a long-running case that has also seen it accused of fraud.

There are allegations related to the drug valproate marketed as dipakin in the name of another drug, which the study says has incapacitated about 15,000–30,000 children whose mothers took the drug while pregnant.

On the market since 1967, the drug has been used to treat epilepsy, migraines and bipolar disorder.

But research found that when pregnant women took the drug, their children had a higher risk of congenital malformations, autism, and learning difficulties – 10 to 40 percent.

Sanofi is facing separate charges of fraud and has inadvertently been hurt in 42 cases filed by families, but insists that it has already led health officials to drug risks in the 1980s Was warned

On Monday, the company confirmed a Le Monde newspaper report that prosecutors have now accused him of manslaughter as well.

But in a statement sent to AFP it insisted it “fulfilled its obligation” to provide information about the drug and its side effects, adding that it “opposes the validity of these proceedings.”

Sanofi said that he has given legal challenge to the indictment.

Under the French legal system, charges do not automatically result in a trial because prosecutors may decide not to proceed based on lack of evidence.

Last month, a French court ordered the state to pay thousands of euros of damages over the scandal, with officials saying it should ensure the drug was not taken by pregnant women.

The court found that health officials were already aware of the risk of birth defects from Dipocaine in 1983, and learning disabilities and autism since 2004.

Another 500 complaints have been filed with France’s National Indemnity Agency for medical accidents, with a 6.5 million-euro ($ 7.6 million) package already proposed for dapkin victims.

French multinational Sanofi is working with Britain’s GSK on a candidate vaccine against the novel Coronavirus, for which it will receive up to $ 2.1 billion from the US government.


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