French drug agency under formal investigation over Levothyrox

PARIS: France's ANSM national drug agency said it is under formal investigation on the possibility of issuing misleading information about German drugmaker Merck's thyroid drug Levothyrox. It added it contested the provisional charges.

The ANSM has never denied the difficulties encountered by some patients during the changeover to the new Levothyrox formula and works for the safety and health of patients every day, ANSM said in a statement late on Monday.

The French Association of Thyroid Patients welcomed the development, but expressed disappointment that the provisional charges had not been more far-reaching.

In a civil litigation case, France's highest court in March upheld a ruling that ordered Merck to pay more than 3,300 people with thyroid problems in France, after it changed the formula of Levothyrox in 2017.

The plaintiffs said that Merck's decision to remove lactose from the drug to make it easier to use had resulted in side effects such as memory loss, weight gain and palpitations.

In October, a court in the French city of Marseille had already placed Merck under formal investigation, so it is treated as a formal suspect but the case may still be dropped.

In October, Merck said that the investigation against it did not deal with the new formula for Levothyrox, but rather the way it provided information when changing from the old one.