The French Association of Thyroid Patients (AFMT) has analyzed the new formula of Levothyrox. Metal nanoparticles have been found. The Merck laboratory formally denies any exceeding of the authorized thresholds.
Iron-chromium, chromium-nickel, iron-chromium-silicon, ferrochrome-aluminum alloys. This is what the doctors who analyzed the new Levothyrox formula found in the new formula. For the French Association of Thyroid Patients (AFMT), these nanoparticles could perhaps explain the side effects felt by patients. In most cases, this is fatigue, headache, insomnia, dizziness, hair loss or joint or muscle pain.
Analyzes conducted on the old and the new formula
These results were presented Wednesday at a press conference, even though a meeting was held at the Ministry of Health to close the case on this drug that has been controversial for several months. In the old version of the drug, some scrap steel was found. It was Dr. Jacques Guillet who analyzed tablets of the old and the new formula under a microscope and spectrometry. "For us, it's not a matter of freaking people out, nanoparticles, we inhale a lot more by walking in the streets of Paris, and we have not put any evidence of cause and effect," says he does, however.
The Merck laboratory denies, the ANSM tempers
"Whether it is the old or the new formula, we recall that the analysis of all heavy metals was carried out in accordance with the regulations in force, and we reaffirm that all these checks were found to comply to specifications, "said Merck Lab (manufacturer and distributor) in a statement.
For the laboratory, the thresholds of heavy metals would therefore be respected in this new formula. The National Agency for the Safety of Medicines had already conducted a study in January on the drug and found the presence of traces of metals. However, it recalls that "the presence of metal traces in health products does not in itself represent a quality defect or a health risk insofar as the concentrations are below the safety thresholds established by the international scientific community. for medicines ".
Many people came to protest Wednesday in Paris, in parallel with the revelation of the results of this new study. Chantal L'Hoir, president and founder of the AFMT, asks for "recognition by the public authorities of this health crisis".
17,000 reported cases of side effects
The Levotyrox case began last July, when the drug formula was changed. This change involved the replacement of lactose, which coated the thyroid hormone levothyroxine to form a tablet with mannitol. It had been requested by the Medicines Agency (ANSM) to guarantee the stability of the product over time, which was not the case with the old formula. This change must be extended to the whole of Europe.
But the patients have experienced unwanted side effects. Of the 2.3 million patients treated in France, 17,000 cases of side effects were identified. In total, 5062 adverse reactions were classified as serious and 14 deaths were recorded by the ANSM, although a direct link with the new formula could be formally established. According to the Ministry of Health, 500,000 people have abandoned the new formula of the drug. An administrative investigation was opened last March, the public prosecutor of Marseille opened a judicial investigation against X for "aggravated deception, involuntary injury and endangering others".