Question 7544 — pharmacy and medications

Summary

Taking into account the consequences of changing the formula of the specialty Levothyrox®, suffered by patients, is a major concern for all health authorities mobilized on the subject. The quality of the new Levothyrox® formula has been scientifically established. The results presented during the pharmacovigilance technical committee, which was held at the national agency for the safety of medicines and health products (ANSM) on July 6, 2018, confirmed the good quality of the new Levothyrox® formula. However, and in accordance with the commitments made by the Minister of Solidarity and Health, so that patients suffering from persistent adverse effects with this medication can benefit from appropriate care, the ANSM is continuing its actions with the aim, in particular, of expanding and diversifying the therapeutic offer of levothyroxine products. In addition to the specialty Levothyrox® "new formula" scored tablet (8 strengths) from the Merck laboratory, four levothyroxine-based medications with long-term marketing authorization (AMM) in France are currently available: - the specialty L-Thyroxin Henning®, scored tablet (8 strengths), from the Sanofi laboratory, - the specialty L-Thyroxine Serb®, oral solution in drops, from Serb laboratory, - the generic specialty Thyrofix®, tablet (4 dosages), from the Uni-Pharma laboratory, - the specialty TCaps®, soft capsule (12 dosages), from Genevrier laboratories. In addition, at the request of the public authorities, the specialty Euthyrox®, identical to the old formulation of Levothyrox®, was made available to patients from October 2017 through temporary imports from the Merck Santé laboratory. The prescription of the specialty Euthyrox® is intended as a last resort for patients who experience lasting adverse effects and have not yet identified the long-term specialty that suits them. On July 18, 2018, the in-depth evaluation of the new Levothyrox® formula carried out by 21 member states of the European Union (worksharing) resulted in a positive opinion which reinforces the favorable evaluation made by the ANSM before the launch of the new formula in France in March 2017. The implementation of the new formula in these Member States and the abandonment of the marketing of the old formula will be carried out over time and gradually. In this perspective, the Merck laboratory announced on November 6, 2018, that it will continue imports of Euthyrox® on a transitional basis during 2019, in order to allow patients experiencing adverse effects to find an alternative that suits them. In addition, the ANSM, in its general health safety mission on behalf of the State and in the interest of patients, is continuing its pharmacovigilance investigation initiated upon the marketing of the new formula, in March 2017. The first three studies of this investigation confirmed the occurrence of thyroid imbalances for certain patients when switching from the old to the new formula. They concluded that the clinical profile of adverse reactions reported with the new formulation was similar to that of adverse reactions reported with the old formulation. In addition, the Agency also initiated a pharmacovigilance investigation into the adverse effects of other levothyroxine-based medications available since October 2017. Finally, the ANSM initiated a pharmacoepidemiology study on all of patients treated on the basis of health insurance data. The comparative analysis of this study, the results of which are expected very soon, aims to estimate the possible risks associated with the transition to the new formula of Levothyrox®. Aware of the adverse effects that certain patients suffer due to this change in formula, the Minister of Solidarity and Health is committed to ensuring that the votes patients are listened to and heard, individually or when they are supported by associations defending the rights of users of our health system. In this context, a monitoring committee led by the General Directorate of Health bringing together all stakeholders including patient associations was set up in order to constitute a privileged framework for exchange within which precise responses to questions that may arise may be provided.  Consequently, the health authorities maintain and will maintain reinforced surveillance of all levothyroxine-based specialties available in France.

Machine translation from French. The official text remains authoritative.

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• Damien Abad · auteur

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