The French subsidiary of German drugmaker Merck KGaA has been indicted by the French courts for 'aggravated deception' as part of ongoing criminal proceedings surrounding change in formula of Levothyrox, a drug for thyroid disorders.
Citing a Merck France statement, French media sources reported that an investigating judge in the Marseilles court has decided to formally investigate the drugmaker in connection with "the information procedures put in place at the time of the transition from the old to the new formula in 2017.” The indictment is part of criminal proceedings that began in 2018.
Back in 2017, Merck KGaA changed the formula of Levothyrox, removing the lactose and replacing it with other additives. After the change, more than 30,000 consumers reported complaints of headaches, insomnia, hair loss or dizziness after taking the new version. The court has accused Merck KGaA of supplying a drug with changes in its composition without notifying patients.
The new formulation was deemed bioequivalent to the previous one and Merck KGaA has reiterated that the quality of the drug is not being called into question. The company says it will continue to cooperate with authorities to resolve the legal matter.
