The French national medicines agency is being investigated for “aggravated deception” in the case of Levothyrox, the thyroid medication whose change in recipe several years ago caused an uproar, it announced this week, adding that it had contested the charges.
The Agence nationale de sécurité du médicament et des produits de santé (ANSM) said the investigation began on Monday.
The French branch of German pharmaceutical giant Merck is also under investigation.
Levothyrox, one of the most common medications to treat underactive thyroid disorders, changed its formula in 2017. Almost immediately, hundreds of the 2.5m patients taking the drug in France reported problems and a return of their symptoms, including cramps, headaches, dizziness, brain fog, fatigue, weight gain, and hair loss.
Complaints soon grew into the thousands, and the inquiry even included a manslaughter accusation, despite the manufacturer insisting the new drug had only been changed in line with ANSM regulations, and that the active ingredients were identical from a medical perspective.
Multiple independent investigations concluded that the drug was bioidentical, despite one victims’ association claiming there were substantial differences, reports ConnexionFrance.
Then-Health Minister Agnès Buzyn announced an investigation into the case, and made the “old formula” of the drug available nationwide in the meantime. Half of the stocks sold out within two days at the time.
In a statement released on Tuesday, the ANSM said: “ANSM will make its full contribution to the demonstration of the truth but firmly disputes the reproaches made against it because no criminal offence has been committed.
“The ANSM has never denied the difficulties encountered by some patients when switching to the new formula of Levothyrox and is constantly and daily concerned about the safety and health of patients.”
In October, the French branch of Merck revealed that it was also under investigation for the same issue.
One of the victims’ lawyers said: “The victims were beginning to lose hope after five years.”
However, one of Merck’s lawyers said that “the quality of the drug is not in doubt” and that the issues had been caused by “the lack of communication in the plan, built under the authority of ANSM”.
The Cour de Cassation (one of the four courts of last resort) has already thrown out Merck’s appeal against a 2020 ruling that it should compensate at least 3 300 users suffering from symptoms experienced after the formula changed.
ConnexionFrance article – Levothyrox France: National medicines agency investigated (Open access)
See more from MedicalBrief archives:
Kinase inhibitor could be viable in thyroid cancer therapy — trial