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 in 2024 and 2025, confirms the Medicines Agency on November 16, 2023. These supplies make it possible to continue supporting patients still treated with Euthyrox towards another specialty based on levothyroxine. These imports are currently ensured by batches of Euthyrox manufactured in Germany and intended for Russia. From the end of 2023, imports of Euthyrox into France will be ensured by batches manufactured in Germany initially intended for Argentina, taking into account the transition to the new Levothyrox formula in Russia. Remember that Euthyrox should not be prescribed as an initiation. 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 was extended until the end of 2023. Ultimately, 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”.
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.
- These boxes include tablets whose formula is strictly identical to the old Levothyrox formula distributed in France until 2017;
- They are still manufactured on the Merck laboratory site located in Darmstadt, Germany. The name ELEA appears on the box, because they are sold by this laboratory in Argentina;
- A notice in French is affixed to these boxes in Spanish;
- Boxes contain 50 tablets (boxes intended for the Russian market contained 100 tablets);
- The same 6 dosages will be available: 25, 50, 75, 100, 125 and 150 mcg.
- Levothyrox and levothyroxine-based medicines: information regarding the availability of Euthyrox – ANSM