Levothyrox: the old formula remains available in France, until when?

Levothyrox the old formula remains available in France until when

The old formula of Levothyrox (Euthyrox), a drug against thyroid problems, will remain available in France in 2024 and 2025. A relief for the 80,000 to 90,000 French patients who are still taking this treatment.

L’old formula of Levothyrox®known asEuthyrox®will remain available in France from “temporary way“, either 2024 and 2025announce Merckthe German laboratory which markets it, and the Ministry of Health, to AFP on September 5, 2023. The extension of this thyroid treatment intervenes at the request of the National Agency for the Safety of Medicines and Health Products (ANSM). Basically, the distribution of the old formula (Euthyrox®), imported since the end of 2017 in France, was to end in 2020 due to the occurrence of adverse effects in 30,000 patients (insomnia, headaches, dizziness…), but it has been extended until the end of 2023. Finally, it will remain available for two additional years in France for “patients who continue to use it every day and who find that this formulation is the one that suits them best“, according to’French Association of Thyroid Patients (AFMT). It will be always in limited quantityand reserved for renewals (no first-time prescription) but for 80,000 to 90,000 French patients who are still taking this medicine, it will undoubtedly be a great relief”, added the association Living without a thyroid on Facebook. A decision that goes in the direction of High Authority of Health who emphasized in 2019 that “for people treated who are well balanced and without adverse effects, there is no need to change treatment.” At the same time, Merck emphasizes “the need for health professionals to support patients in finding the long-term treatment that suits them bestin order to anticipate the day when this old formula will no longer be available at all”. “These transitional imports are made from batches intended for the last countries which have not yet switched to the new formula of the drug and manufactured in a manner strictly identical to the old Levothyrox formulai.e. Germany then Russia until 2023 then Argentina from the end of this year“, explains the Merck laboratory.

More than 18 million patients in Europe treated with the new formula

The old and new formulas of Levothyrox® are indicated in cases ofhypothyroidism and are composed of the same active molecule: levothyroxine. The only difference is that they use excipients different (neutral elements such as preservatives, emulsifiers which simply serve to incorporate the active ingredients). Problem: these excipients are more or less well tolerated by patients and some patients experience side effects. According to the Merck laboratory, more than 18 million patients in Europe are treated daily with the new Levothyrox® formula.

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