Pharmaceutical firm Sanofi is being investigated by French prosecutors for manslaughter over birth defects associated with an epilepsy drug Depakine.
The studies indicated that the Depakine has induced disabilities in about 15,000 to 30,000 children whose mothers took the drug valproate during pregnancy.
The drug, which has been in the market since 1967, is used for the treatment of epilepsy, migraines and bipolar disorder.
As per the data from the research, the children had an increased risk between 10% and 40% when pregnant women took the drug. It may result in disabilities such as congenital malformations, autism and learning difficulties.
Sanofi has also stated that it has filed a legal challenge over the allegation.
The French drugmaker denied wrongdoing and said that it alerted the health authorities regarding the risks that resulted due to the drug in the 1980s.
In France, the legal system enables to prevent a trial to advance further if the prosecutors fail to provide the required evidence.
Separately, Sanofi and GSK announced a collaborative effort with the US government to optimise the development and manufacturing of a Covid-19 recombinant protein-based vaccine.
The vaccine candidate, developed by Sanofi in collaboration with GSK, is based on the recombinant protein-based technology used by Sanofi to produce an influenza vaccine and GSK’s pandemic adjuvant technology.
Sanofi is engaged in the research and development, manufacturing and marketing of pharmaceutical drugs primarily in the prescription market. It also offers over-the-counter medication solutions.