A new episode in the thick Levothyrox file.
This Monday evening, the National Medicines Agency announced in a press release that it had been indicted by the examining magistrate in charge of carrying out the investigations on the new formula of this drug.
This indictment was decided for alleged acts of deception.
The ANSM announces that it has in turn been indicted for deception in the #Levothyrox affair, a month after the Merck laboratory.
In question, the new formula of the drug, launched in March 2017 but questioned by many patients suffering from adverse effects.
— Nicolas Berrod (@nicolasberrod) December 5, 2022
In its press release, the ANSM adds that it has never denied "the difficulties encountered by certain patients when switching to the new formula of Levothyrox".
She then indicates that she contests "firmly the reproaches made against her because no criminal offense has been committed".
Merck indicted last month
It has been five years since a legal battle was launched against the new formula of the drug for thyroid patients, put on the market in 2017. But several thousand patients quickly complained of serious side effects.
Between March 2017 and April 2018, at least 31,000 patients said they suffered in particular from headaches, insomnia, or dizziness.
The Merck laboratory, which manufactures Levothyrox, was sentenced in 2020 for lack of information.
A new step was taken on October 19, with the indictment of the French subsidiary of the German pharmaceutical laboratory, for aggravated deception.
He had reacted with words quite similar to those chosen by the ANSM on Monday, indicating his intention to “read all the elements of this file and provide any necessary clarification in order to establish that no criminal offense (… ) has been committed”.
In the civil part of the case, the Court of Cassation last March rejected the appeal of the group, sentenced in 2020 to compensate more than 3,300 users who suffered from side effects following the change of formula.
The court had considered that the manufacturer of a drug that does not explicitly indicate a change in the formula of its drug can be accused of a lack of information ", which could " cause moral damage ".