The Merck laboratory plans to launch the new Levothyrox formula in 21 countries of the European Union. Spain, where many French patients dissatisfied with the drug had become accustomed to stocking up, is also concerned.
From 2019, the Merck laboratory plans to launch the new Levothyrox formula in 21 countries of the European Union. "Several official reports of expertise published these last days allow to once again attest to the quality of the new Levothyrox® formula and to comfort the 2.5 million French patients who, for more than one year, have found Their renewed confidence in the new Levothyrox® formula in France also echoes the positive opinion given at the European level on 18 July, after a thorough evaluation phase in the regulatory procedure. to allow 21 Member States to market the new Levothyrox® formula, "the company said in a statement.
Spain, where many French patients dissatisfied with the new formula had become accustomed to stocking up, is also concerned. In fact, the thyroid drug will no longer be available anywhere in Europe, since the 7 countries not involved in the measure, such as Italy, market slightly different compositions. The Council of State also rejected the request of French patients who urgently requested measures to ensure the availability of the old formula. Today, four new Levothyrox formula competitors are available: L-thyroxin Henning, Thyrofix, L-thyroxine SERB and TCAPS.
Unwanted side effects
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.
Problem: Patients have experienced unwanted side effects (fatigue, headache, insomnia, dizziness, joint and muscle pain and hair loss). 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.
Two notorious changes
In a statement dated June 14, the French Association of Thyroid Patients (AFMT) said it had ordered a foreign laboratory a new analysis of the controversial formula of the drug. According to her, first results highlight two notable changes compared to the previous formula. First, it would contain less levothyroxine than the specifications in force. The slightest 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.
In addition and still according to this structure, its analysis shows the presence in the drug of dextrothyroxine while it does not appear 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.
1,200 disgruntled patients have already complained
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 ". 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, in principle, precaution, withdrawal of Levothyrox ". About 1,200 disgruntled patients have already filed a complaint against Merck.
Three reports from the French Medicines Agency (ANSM) indicate that the adverse effects of the new formula are identical to those already known with the old formula. The agency also reports that there are many more, without being able to explain why.