The mission “on improving information on drugs” has just submitted a report to the Minister of Health Agnès Buzyn on the recent health scandals, including that of Levothyrox.
Levothyrox, Dépakine, Mediator … In recent years, health scandals follow and resemble each other. To put an end to it, the Minister of Health Agnès Buzyn ordered a report “on the improvement of information on the drug” which was given to her on Monday.
The team of doctor Gérald Kierzek and Magali Leo have identified seven recurring problems in this type of crisis. Among them, “the lack of anticipation” of the public authorities, “the absence of reaction to the many signals easily spotted on the Web”, the “badly chosen” moment to communicate, and the “minimization of the feelings of patients and the legitimacy of their reports “.” The nocebo effect was very quickly mentioned to explain side effects […] Even such an effect cannot disqualify the reality of the complaints expressed by the thousands of patients, ”the report said.
Improve communication around drugs
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, 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). In total, 17,000 cases of side effects were identified, of which 5,062 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.
The mission thus proposes the creation of a platform Drug Info Service, made up of a general public website and a telephone line for healthcare professionals. A single point of contact is also recommended, as well as an anticipation structure: Vigimedicine. In addition, the report encourages people to “introduce the subject into school curricula”, starting in primary school. Finally, the distribution of “urgent messages on the digital display windows of pharmacies” and the sending of SMS to patients during a major change of formula are recommended. All to improve communication around these drugs. In particular around Levothyrox, whose new formula will soon be sold in 21 countries of the European Union.
New Levothyrox formula soon to be sold in 21 EU countries
From 2019 in fact, the Merck laboratory plans to expand its field of action. “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.
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