The National Agency for the Safety of Medicines and Health Products (ANSM) announced that it was charged this Monday for “deception” in the case of changing the formula of Levothyrox, this drug designed against thyroid problems.
This accusation comes a month and a half after that of the French subsidiary of the German pharmaceutical laboratory Merck, manufacturer of this drug, for “aggravated deception.”
At the center of this case: the new composition of Levothyrox, which arrived in France at the end of March 2017 and uses the same active ingredient, levothyroxine, but with new excipients.
More than a thousand plaintiffs
However, patients have complained of many side effects: cramps, headaches, dizziness, or hair loss. In March 2018, a criminal investigation was opened in Marseille to shed light, while this drug is used daily by 2.5 million patients in France, according to Merck.
“The ANSM has never denied the difficulties encountered by certain patients when switching to the new Levothyrox formula and is constantly and daily concerned about the safety and health of patients,” says the French agency that controls the safety of medicines in a press release issued on Monday.
In June 2019, the ANSM had carried out a study on more than two million patients and concluded that the change to the new formula had not caused “serious health problems”. This agency is now the subject of a class action of some 1,100 plaintiffs, for “lack of vigilance” and “lack of anticipation.”
Elsewhere, in civil matters, the Court of Cassation had rejected in March the appeal of Merck, sentenced in 2020 to compensate more than 3,300 users who suffered side effects after the formula change.
In France, less than 100,000 patients are treated with the old formula, imported since the end of 2017 under the name Euthyrox. The distribution of the old formula, which was to cease in 2020, has been extended at least until the end of 2022
Source: BFM TV
