The mission "on improving information on the drug" has just submitted a report to the Minister of Health Agnès Buzyn on recent health scandals, including that of Levothyrox.
Levothyrox, Dépakine, Mediator ... In recent years, health scandals have followed one another and are similar. To end it, Health Minister Agnès Buzyn commissioned a report "on improving information on the drug" that was given to him on Monday.
The team of Dr. Gerald Kierzek and Magali Leo have identified seven recurring problems in this type of crisis. Among them, the "lack of anticipation" of public authorities, "the lack of reaction to the many easily identifiable signals on the Web", the "poorly chosen" moment to communicate, and the "minimization of the feelings of patients and the legitimacy of their reports ". "The nocebo effect was very quickly evoked to explain side effects ... Even such an effect can not disqualify the reality of the complaints expressed by the thousands of patients," says the report.
Improve communication around medicines
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, 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 adverse side effects (fatigue, headache, insomnia, dizziness, joint pain, muscle and hair loss). In total, 17,000 cases of side effects were identified, of which 5062 were classified as serious and 14 deaths were recorded by the ANSM, without a direct link with the new formula can be formally established. According to the Ministry of Health, 500,000 people have abandoned the new formula of the drug.
The mission proposes the creation of a platform Drug Info Service, consisting of a consumer website and a telephone line for health professionals. A single interlocutor is also recommended, as well as an anticipation structure: Vigimédicament. In addition, the report encourages "to introduce the subject in the curricula", and this as of the primary school. Finally, a dissemination of "urgent messages on the digital showcases of pharmacies" and sending SMS to patients during a major change of formula are recommended. All to improve communication around these drugs. Notably around Levothyrox, whose new formula will soon be sold in 21 countries of the European Union.
New Levothyrox formula soon sold in 21 EU countries
From 2019 onwards, the Merck laboratory plans to expand its field of action. "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.