The French Association of Thyroid Patients (AFMT) claims to have commissioned an analysis of the new Levothyrox formula at a foreign laboratory. The results show the underdosing of one molecule and the presence of another, not present in the list of components. Which would explain, according to the association, the side effects which suffer many patients.
The battle of the thyroid patients against the new formula of Levothyrox continues. While it had already ordered at the beginning of May an analysis of nanoparticles of metal in the new formula of the drug of the Merck laboratory, the French Association of the patients of the thyroid (AFMT) continues its fight.
In a statement dated June 14 and relayed by FranceInfo, the association said it had ordered a foreign laboratory a new analysis of the controversial formula of the drug. According to her, the results highlight two notable changes from the previous formula.
Wake up to sleeping cancers and side effects
First, it would contain less levothyroxine than the specifications in force. According to the AFMT, the lesser presence of this synthetic thyroid hormone would be at the origin of the dysfunctions of the treatment observed in the patients. "Cancer patients are under-dosed in thyroid hormones, we have observed a consistent awakening cancer sleeping for years," says the association.
Moreover, according to the association, the analysis ordered by the association shows the presence in the drug dextrothyroxine while it is not in the list of components. Not marketed in France, this synthetic substance has been banned in the United States because it is suspected of causing the same side effects as those currently complaining of thyroid patients using the new Levothyrox formula.
AMFT calls for the resignation of Agnès Buzyn
The AMFT has indicated that the results of the study of the new formula of Levothyrox have been sent to an investigating judge of the Marseille health unit in charge of the case, opened for "aggravated deception, unintentional injuries and endangerment. others ".
Interviewed by FranceInfo, Chantal L'Hoir, President of the French Association of Thyroid Patients, calls for the resignation of the Minister of Health Agnès Buzyn, as well as recognition "emergency" of health crisis "and, by precautionary principle, with the withdrawal of Levothyrox ".
"There were three and a half million lots sold at the time, per month. (...) So we can not take a risk.In a country that calls itself a scientist, it is not worthy," says -she. "The Ministry of Health has only to make a recognition of health crisis with urgency, for reimbursement for example TCAPS alternative Levothyrox laboratory Juniper they blocked."
A statement "scientifically unfounded" according to Merck
For its part, the Merck laboratory, which markets the new formula of Levothyrox, said in a statement that the statement of the AMFT was "scientifically unfounded".
"We formally deny the presence of dextrorotatory form in Levothyrox tablets, whether it is the old or the new formula (...) Regarding the presence of a different form of levothyroxine in the new formula of Levothyrox (form Dextrogyre D-T4), we formally affirm that this is not the case We recall that the active substance used for Levothyrox new formula is strictly identical to that present in the old formula of Levothyrox (form Levogyre called L -T4 molecular form) ", continues the laboratory by Valérie Leto, Chief Pharmacist of Merck and author of the press release.
The Levotyrox case began in February 2017, 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. This change had been requested by the French Medicines Agency (ANSM) to ensure the stability of the product over time, which was not the case with the old formula.
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.