The Merck laboratory plans to launch the new formula of Levothyrox in 21 countries of the European Union. Spain, where many French patients dissatisfied with the drug had taken to obtaining supplies, is also concerned.
From 2019, the Merck laboratory plans to launch the new formula of Levothyrox in 21 countries of the European Union. “Several official expert reports published in recent days have once again confirmed the quality of the new formula of Levothyrox® and reassured the 2.5 million French patients who, for more than a year, have found their thyroid balance thanks to it. This renewed confidence in the new formula of Levothyrox® in France also echoes the positive opinion delivered at European level on July 18, after an in-depth evaluation phase within the framework of the regulatory procedure. aimed at enabling 21 member states to market the new formulation of Levothyrox®, “the company said in a press release.
Spain, where many French patients dissatisfied with the new formula had gotten into the habit of getting supplies, is also concerned. In fact, the thyroid drug will no longer be available anywhere in Europe, since the 7 countries not concerned by the measure, such as Italy, market slightly different compositions. The Council of State also rejected the request of French patients who urgently demanded measures to ensure the availability of the old formula. Today, four competitors to the new formula Levothyrox are available: L-thyroxin Henning, Thyrofix, L-thyroxine SERB and TCAPS.
Undesirable side effects
The Levotyrox case began in February 2017, when the formulation of the drug was changed. This change consisted of replacing the lactose, which coated the thyroid hormone, levothyroxine, into a tablet, with mannitol. This modification had been requested by the Medicines Agency (ANSM) in order to guarantee the stability of the product over time, which was not the case with the old formula.
Problem: the patients felt unwanted side effects (fatigue, headaches, insomnia, dizziness, joint and muscle pain and hair loss). Of the 2.3 million patients treated in France, 17,000 cases of side effects have been identified. In total, 5,062 adverse reactions were classified as serious and 14 deaths were recorded by the ANSM, without a direct link with the new formula being able to be formally established. According to the Ministry of Health, 500,000 people have abandoned the new formula of the drug.
Two notable changes
In a press release dated June 14, French Association of Thyroid Patients (AFMT) had said he had ordered a new analysis of the controversial formulation of the drug from a foreign laboratory. According to her, initial results highlight two notable changes compared to the previous formula. First, it would contain less levothyroxine than the specifications in force. The lesser presence of this synthetic thyroid hormone is believed to be the cause of the treatment dysfunctions observed in patients. “Cancer patients are underdosed in thyroid hormones, we have consistently observed awakenings from dormant cancers for years,” says the association.
In addition and always according to this structure, its analysis shows the presence in the drug of 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 complained of by thyroid patients using the new formula of Levothyrox.
1,200 dissatisfied patients have already lodged a complaint
The AMFT announced that the results of the study of the new formula of Levothyrox were transmitted to an investigating judge of the Marseille health center in charge of the case, opened for “aggravated deception, involuntary injuries and endangering of ‘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 for the recognition “in urgency” of health crisis “and, in principle of precaution, with the withdrawal of Levothyrox “. About 1,200 dissatisfied patients already have filed a complaint against Merck.
Three reports of Medicines Agency (ANSM) indicate for their part that the undesirable 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.
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