The Levothyrox file is experiencing a new important legal episode. The National Agency for the Safety of Medicines and Health Products (ANSM) announced that it was indicted on Monday, December 5, for “deception” after the change in formula of this treatment designed to fight against thyroid problems.
This indictment comes a month and a half after that of the French subsidiary of the German pharmaceutical laboratory Merckmanufacturer of Levothyrox, for “aggravated deception”.
At the heart of this case is 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, i.e. the other substances which make it possible to give the medicine its shape (tablet, capsule, syrup), improve its preservation or modify the taste.
Or, of patients complained of many side effects : cramps, headaches, dizziness or hair loss. A criminal investigation was opened in Marseille in March 2018while this drug is used daily by 2.5 million patients in France, according to Merck.
Aware of a potential problem
The ANSM is now the target of a collective action launched in September 2021 by some 1,100 complainants, for “lack of vigilance” and “lack of anticipation”. According to a 2021 expert report requested by the Marseille court, the agency was aware, as early as September 2017, of a potential problem. However, the drug policeman did not take any corrective measures, nor even recognize, in the following months, the possible pharmacological origin of the disorders declared by the patients.
In October 2017, the ANSM ensures that the adverse effects are due to “thyroid imbalance” caused by the change in treatment and not to the new formula. The agency confirms, in July 2018, “the good quality of the new formula”.
In June 2019, the ANSM conducted a study on more than two million patients and concluded that the switch to the new formula did not cause any “serious health problems”.
The agency “strongly disputes the accusations” against it
“The ANSM has never denied the difficulties encountered by some patients when switching to the new Levothyrox formula and is constantly and daily concerned about the safety and health of patients”, assures the institution in a statement released Monday evening. She “will make its full contribution to the manifestation of the truth, but strongly contests the reproaches made against it, because no criminal offense has been committed”she argues.
In another aspect, in civil matters, the Court of Cassation rejected Merck’s appeal in Marchsentenced in 2020 to compensate more than 3,300 users who suffered side effects following the change of formula.
In France, less than 100,000 patients are treated with the old formula of Levothyrox which returned to pharmacies in October 2017 under the name Euthyrox. The distribution of the old formula, which was to stop in 2020, has been extended at least until the end of 2022.