the new formula arrives in 21 European countries, including Spain

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 attest once again of the quality of the new formula of Levothyrox® 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 badessment 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.

Adverse side effects

The Levotyrox case began in February 2017, when the formula of the drug has been changed. This change involved the replacement of lactose, which coated the thyroid hormone levothyroxine into a tablet with mannitol. This modification had been requested by the French Medicines Agency (ANSM) to guarantee the stability of the product over time, which was not the case with the old formula.

Problem: the patients felt effects unwanted side effects (fatigue, headaches, insomnia, vertigo, 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 clbadified 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) had declared to have commissioned a foreign laboratory to retest the controversial formulation 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. "Patients with cancer are under-dosed with thyroid hormones, we have consistently seen cancer awakenings that have been dormant for years," says the badociation.

Moreover and always according to this structure, his badysis shows the presence in the drug of dextrothyroxine whereas 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 that those currently complaining of thyroid patients using the new Levothyrox formula.

1 200 disgruntled patients have already lodged a complaint

The AMFT has indicated that the results of the study of the new formula of Levothyrox have been transmitted to an examining magistrate of the Marseille health unit in charge of the file, opened for " aggravated deception, unintentional injuries and endangering 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" health crisis "and, in principle, precaution, the removal of Levothyrox ". About 1,200 disgruntled patients have already filed a complaint against Merck.

Three reports from the Agence du médicament (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.