While this Wednesday, May 2, 2018 took place in Paris the follow-up committee of the Ministry of Solidarity and Health on the new Levothyrox file, the French Association of Thyroid Patients (AFMT) was demonstrating in front of the National Assembly for denounce the presence of metal nanoparticles in the drug.

According to her, these substances could be at the origin of the numerous side effects felt by the patients since the change of formula a year ago . The association asks the justice to look at this track as soon as possible and wishes the recognition of a "sanitary crisis".

Iron, chromium, aluminum ... Several heavy metals found in the new formula

"These nanoparticles are iron-chromium, chromium-nickel, iron-chromium-silicon, ferrochrome-aluminum alloys, whereas in the old formula there were only a few pieces of steel," explained Dr. Jacques Guillet, MD and nuclear medicine specialist, who performed analyzes on tablets of Euthyrox (old formula) and Levothyrox new formula at the request of the association.

"We can not say that there is danger, but the fact is that there was none before.It is known that nickel can cause particular allergies," he says.

A simple "announcement effect" according to the manufacturer

A theory formally rejected by the Merck laboratory, the manufacturer of the drug: "Be it old or new formula, we recall that the analysis of all heavy metals was conducted in accordance with regulations in force, and we reaffirm that all these checks have been found to comply with the specifications, "the group said in a statement.

On France Info, he "condemns with the utmost firmness this type of untruth and announcement effect that only worries patients without supporting any scientific evidence."

The results of the continuation of the pharmacovigilance survey expected for July 2018

On the same day, the Ministry of Health also issued a press release on the issues addressed by the levothyroxine drug monitoring committee, composed of patient associations, health professionals, the General Directorate of Health (DGS) as well as the National Agency for Safety of Medicines and Health Products (ANSM).

"The results of the continuation of the pharmacovigilance survey on Levothyrox and the survey extended to all levothyroxine proprietary medicinal products will be presented to the Technical Committee for Pharmacovigilance (CTPV) to be held next July at ANSM. They will then be presented to stakeholders at a follow-up committee, "he says.

Similarly, it states that the analyzes carried out by the ANSM made it possible to verify that the composition was in conformity with that mentioned in the marketing authorization (MA) file and that the presence of metals in the state of traces detected in all levothyroxine proprietary medicinal products "does not in itself represent a defect in quality or a health risk since the concentrations are below the safety thresholds established by the international scientific community for medicinal products." Similarly "the latest analysis conducted in February 2018 confirmed the absence of butylated hydroxytoluene (BHT) in tablets of new formula Levothyrox and Euthyrox."

Finally, "the Information and Medicines mission will submit its report to the Minister of Solidarity and Health at the end of May, with proposals for improving information on the drug intended for patients and health professionals."

On the judicial side, a judicial investigation against X was opened Friday, March 2, 2018 for aggravated deception, involuntary injury and endangering others and entrusted to a judge of the public health pole of the TGI of Marseille. To date, nearly 7000 patient complaints have been filed throughout France.

Reminder: a toll-free number (0.800.97.16.53) is available from Monday to Friday from 9 am to 7 pm to answer questions from patients.