Sanofi Faces Charges Over Valproate Birth Defects
French Regulator Planning More Preventive Measures
In a case that has parallels with that of Servier’s diabetes drug Mediator, Sanofi has been indicted over its alleged lack of transparency over the birth defects associated with use of its valproate drug in pregnant women.
You may also be interested in...
A trial has begun in France to investigate the roles of the French firm Servier and the former drug regulator AFSSAPS in the Mediator scandal, where an amphetamine-like drug was kept on the market despite mounting evidence of its cardiac side-effects.
Following the endorsement of EU-wide restrictions on the safe use of anti-epilepsy drug valproate, the UK appears to be the first member state to put in place a pregnancy prevention program to reduce the number of pregnancies exposed to valproate medicines to an absolute minimum and make sure all women and girls of childbearing potential are aware of the risks.
A number of countries are resorting to extreme measures such as export bans to preserve stocks of medicines for the COVID-19 pandemic. Belgium is among the latest to impose an export prohibition, but might it fall foul of the EU’s export regulations?