The new formula of this medication designed against thyroid problems had caused many side effects in 2017 in 2017 in patients.
mo12345lemonde with AFP
The Levothyrox file is experiencing a new judicial episode. The National Agency for the Safety of Medicines and Health Products (ANSM) announced that it has been indicted on Monday, December 5, for “deception” after the change of formula of this medication designed against thyroid problems.
This indictment comes a month and a half after that the French subsidiary of the German pharmaceutical laboratory Merck, manufacturer of this drug, for “aggravated deception”.
At the heart of this case is the new composition of Levothyrox, arrived in France at the end of March 2017 and using 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 survey 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 agency “firmly disputes the reproaches “against him
“The ANSM has never denied the difficulties encountered by certain patients at the time of the new Levothyrox formula and is constantly and daily concerning patient safety and health”, assures the French agency controlling the safety of drugs in a statement released on Monday evening. She “will bring her full contribution to the manifestation of the truth but firmly disputes the reproaches formed against her, because no criminal offense has been committed,” she said.
In June 2019, the ANSM had conducted a study on more than two million patients and concluded that the transition to the new formula had not caused “serious health problems”. This agency is today targeted by a collective action of some 1,100 complainants, for “lack of vigilance” and “lack of anticipation”.
In another component, in civilian, the Court of Cassation had rejected in March the appeal of Merck, sentenced 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 under the name of Euthyrox. The distribution of the old formula, which was to stop in 2020, was extended at least until the end of 2022.