Question 35829 — pharmacy and medications

Summary

In January 2020, the health authorities were informed of the end in September 2020 of the distribution in France through imports of the specialty Euthyrox – a drug equivalent to the old formula of the specialty Lévothyrox. In the context of the global health crisis linked to the COVID-19 epidemic, the National Agency for the Safety of Medicines and Health Products (ANSM) asked MERCK laboratories to implement every effort is made to continue imports beyond this date, so that the patients concerned can have additional time to initiate the change of treatment towards a lasting therapeutic alternative. An import authorization to this effect was issued by the ANSM on January 20, 2021, allowing the distribution of Euthyrox, which has therefore not been interrupted to date, to exceptionally continue at least until end of 2021. However, since the new formula is gradually introduced in other countries and in particular in the European Union, the importation of a product equivalent to the old formula of Levothyrox cannot continue. However, according to various monitoring data, in February 2020, 75,000 patients were still treated with this drug out of the 3 million patients treated with levothyroxine. To the extent that the number of patients thus treated with an imported medicine, which is a device by nature exceptional and temporary, is an important point of vigilance, the health authorities will closely monitor the evolution of the situation. The number of patients still on Euthyrox will be monitored and, in order to best support the substitution of levothyroxine-based treatment, practical recommendations for the attention of patients and health professionals, were disseminated in May 2020 and updated in August 2020. This document, available on the websites of the Ministry of Health and the ANSM, developed in collaboration in particular with professional orders, provides a logbook for monitoring levothyroxine treatment and mentions in particular the numerous therapeutic alternatives which are to date fully authorized in France, in term of a scientific evaluation carried out by the ANSM, and the prescription of which must be favored. Once imports end, patients currently taking Euthyrox will be able to be prescribed by their treating physician, among these therapeutic alternatives, the specialty most suited to their clinical situation. Measures are therefore effectively implemented in order to offer real and diversified solutions to patients. having felt and still feeling adverse effects with the new formula of Levothyrox, doctors can exercise their freedom of prescription among these possibilities in order to determine the most suitable treatment for the patients concerned. The specialty Levothyrox, in its new formula available since March 2017, is nevertheless widely dispensed to date; it was authorized because it is better suited than the old formula, which was less stable and therefore potentially the cause of less regular hormonal balance in patients as well as adverse effects.

Machine translation from French. The official text remains authoritative.

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