A piece of news that comes the day after the accusation of the ANSM. The distribution of the old Levothyrox formula will continue in France in 2023, information released by patient associations and confirmed this Wednesday to AFP by the Ministry of Health and the Merck laboratory, which produces this drug.
“We have confirmed that the Merck laboratory guarantees the supply of the French market with specialty Euthyrox for the year 2023,” the general health directorate (DGS) told AFP.
“Imports will continue to come from production destined for the Russian market and will always correspond to the Euthyrox formula, strictly identical to the old formula of the Levothyrox specialty distributed in France until 2017,” the same source specifies.
100,000 patients treated
Patient associations, such as the French Association of Thyroid Patients (AFMT) or Thyroid Alert, have celebrated in recent days having “obtained” this extension, highlighting the first “great relief for the 90,000 patients affected” by this treatment designed for problems of thyroid. .
In France, less than 100,000 patients are treated with the old formula, imported since the end of 2017 under the name Euthyrox. The distribution of the old formula, which was due to stop in 2020, was extended several times, in the context of a legal battle over the new formula.
“For several years, Merck has responded positively to the request of the National Agency for Drug Safety (ANSM) by importing Euthyrox on a temporary and transitory basis to France, strictly identical to the old Levothyrox formula but intended for other markets,” stressed the lab for you. “We agreed some time ago to extend these imports again, still temporarily, until the end of 2023,” Merck added.
However, the laboratory insisted, for the attention of the health authorities, “on the need to support patients in the search for the long-term treatment that best suits them, to prevent them from finding themselves in a blind alley the day they that this old formula will no longer be available.”
The ANSM was indicted this Monday for “deception” in the file related to the new Levothyrox formula, a month and a half after that of the French subsidiary of the German laboratory Merck for “aggravated deception”.
At the bottom of the case: the new composition of the drug designed against thyroid problems, which arrived in France at the end of March 2017 and uses the same active ingredient, levothyroxine, but with new excipients.
Between March 2017 and April 2018, some 31,000 patients suffering from headaches, insomnia, dizziness and other side effects blamed the new formula. In March 2018, a criminal investigation was opened in Marseille into this case.
Source: BFM TV
