A new shutter opens in the business of the new formula of Levothyrox, this drug prescribed mainly for problems of thyroid. Wednesday, October 19, it was through a press release that the French subsidiary of the German pharmaceutical laboratory Merck announced its indictment for “aggravated deception”.
“The president of Merck in France was heard” Tuesday at the health center of the Marseilles court, explains the group, hearing at the end of which “the examining magistrate decided to put the company Merck in examination for aggravated deception “.
The methods of information during the change of medication referred to
The indictment is linked to the “information procedures put in place at the time of the transition from the old to the new formula in 2017”, specifies the company. In other words, Merck would not have communicated sufficiently well on the change in formula of the drug to patients.
“This indictment does not in any way concern the quality of the new formula of Levothyrox”, assures the laboratory, stressing that it wants to “provide all necessary clarification in order to establish that no criminal offense, of any nature whatsoever, has been committed.” In the civil part of the case, the Court of Cassation had rejected in March the appeal of the group, condemned in 2020 to compensate more than 3,300 users who suffered from side effects following the change of formula. In its judgment, the highest French court had considered that “when the composition of a drug changes and this change in formula is not explicitly indicated in the instructions, the manufacturer and the operator may be accused of a lack of ‘information’, capable of ‘causing moral harm’.
A case that has been going on since 2017
The whole affair begins in March 2017, when Merck markets a new formula of Levothyrox. A few weeks later, several thousand patients, who until now tolerated the old formula, complained of adverse effects, including headaches, weight gain, hair loss and even digestive problems. In September 2017, the Minister of Health at the time, Agnès Buzyn, then reported nearly 9,000 complaints from patients on Levothyrox.
In 2018, the old formula of Levothyrox, renamed Euthyrox, is marketed for patients. While in June 2019, a study conducted by the National Medicines Agency (ANSM) on more than 2 million patients concluded that the switch to the new Levothyrox formula did not cause “serious health problems”.
Today, less than 100,000 patients are treated with the old formula, Euthyrox. In addition, some 2.5 million patients use the new Levothyrox formula daily, according to Merck. However, six other laboratories have developed formulas based on levothyroxine, now marketed, in order to diversify the offer.