An important step but still insufficient. Associations of patients treated with Levothyrox accepted on Tuesday the accusation of the National Agency for Medicines Safety (ANSM) for “cheating” in the file linked to the new formula of the drug, sometimes even judging it as “insufficient”.
“logical sequence”
A month and a half after that of the French subsidiary of the German laboratory Merck for “aggravated deception”, this accusation marks “an important new step in the legal aspect of the Levothyrox matter”, greeted one of the civil parties of the associations, the French . Association of Thyroid Patients (AFMT), in a press release.
For her, however, the charges for “deception” and “aggravated deception” remain “grossly insufficient”, while more serious grounds have been dismissed.
“It was time that we put the Agency before its responsibilities”, reacted another association, Living without thyroid, hoping that the rest of the procedure “will allow updating the many errors, failures, collusions” of the ANSM.
I Catherine Colin-Chauley, president of a third association, Alert Thyroid, valued the accusation of the ANSM as “a logical continuation”.
Side effects
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 to shed light, while this drug is used daily by 2.5 million patients in France, according to Merck.
On Monday night, the ANSM assured that “it will make its full contribution to the manifestation of the truth, but strongly rejects the accusations made against it, because no crime has been committed.”
Lack of awareness
In June 2019, the ANSM had carried out a study on more than two million patients and concluded that the change to the new formula had not caused “serious health problems”.
So, “we saw that something had gone wrong and that forced us to look closely,” Professor Philippe Lechat, former director of drug evaluation at ANSM, pleaded at the end of September in Le Parisien.
For him, the ANSM “did not sufficiently sensitize doctors”, while “more marked information would probably have avoided this Levotirox issue, because professionals could have made the necessary dose adjustments”.
This agency is now the target of a class action lawsuit involving some 1,100 plaintiffs.
Source: BFM TV
