The National Agency for the Safety of Medicines and Health Products is in turn overtaken by the Levothyrox scandal.
The ANSM thus announced that it had been indicted on Monday for “deception” in the case of the change in formula of this drug designed against thyroid problems.
This indictment 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".
A criminal investigation opened in 2018
At the heart 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.
However, patients have complained of many side effects: cramps, headaches, dizziness or hair loss.
A criminal investigation was opened in Marseille in March 2018 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 with the safety and health of patients”, assures the French agency controlling drug safety in a press release issued Monday evening.
She "will make her full contribution to the manifestation of the truth but strongly contests the reproaches made against her, because no criminal offense has been committed".
In June 2019, the ANSM had conducted a study on more than two million patients and concluded that the switch to the new formula had not caused "serious health problems".
This agency is now targeted by a collective action of some 1,100 plaintiffs, for “lack of vigilance” and “lack of anticipation”.
In another part, in civil matters, the Court of Cassation had rejected in March the appeal of Merck, condemned in 2020 to compensate more than 3,300 users who suffered from side effects following the change of formula.
In France, less than 100,000 patients are treated with the old formula, imported since the end of 2017 under the name of Euthyrox.
The distribution of the old formula, which was to stop in 2020, has been extended at least until the end of 2022.
Levothyrox: From the new formula to the indictment, back on a health scandal
Levothyrox case: Merck laboratory indicted for "aggravated deception"