The distribution of the old form of this medication for the hypothyroidism that had to stop in September is extended following criticism of the new formula.
A turnaround, and a relief for tens of thousands of patients. The old formula of the drug against hypothyroidism Levothyrox, the distribution of which was to stop at the end of September, will finally be available until the end of 2021, according to a letter from the ministry of Health disseminated by a association of patients. Several associations were calling for this extension, arguing that neither the new formula of the Levothyrox marketed by Merck since 2017, or any other comparable drug recently put on the market were not suitable for some patients.
At the end of a monitoring committee held on 6 July at the ministry of Health, “the MAN has asked Merck to put everything in place to maintain the specialty Euthyrox in France beyond September 2020. (…) Laboratories Merck have responded favorably to this request. Thus, the maintenance of Euthyrox in France will continue there in 2021”, says the general Directorate of health (DGS) in a letter dated Friday, broadcast by the French Association of patients of the thyroid (AFMT). Contacted by AFP, the DGS has confirmed the dispatch of this letter.
95, 000 patients treated with the old formula
The Euthyrox is a medication initially intended for the Russian market, corresponding strictly to the old formula of the specialty Levothyrox, and being the subject of an import on a temporary basis”, recalls the ministry. In the first quarter of 2020, approximately 95, 000 patients were still treated with the old formula, “which is 3.1% of the 3 million patients treated by levothyroxine”, the active principle of this drug, estimated the ministry in July.
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“This extension of distribution Euthyrox will offer patients concerned additional time to initiate the change of treatment as soon as possible for a therapeutic alternative perennial”, writes the DGS in e-mail. An announcement described by the AFMT of”immense relief” to the patients involved, which “were in danger of being suddenly deprived of the medicine that suits them”.
According to the association, it is a “radical change of position” of the health authorities, because at the end of the follow-up committee of 6 July, the ministry described the end of the distribution of Euthyrox in September of”irrevocable” and referred only to the need “to support the judgment of distribution of this drug”.
Access to care is still disrupted
During the follow-up committee, the associations AFMT, UPGCS and VST had reiterated their opposition to this judgment, and referred to as “the major health risk that there would be to implement such a substitution (editor’s note : treatment) in a period of full Covid”, with access to medical care is still disrupted. According to the AFMT, the DGS explained that this change “the situation on the front of the Covid” and the delay taken by Merck in the switch to the new formula of the Levothyrox especially in Russia.
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the new formula of The Levothyrox, modifying some of its excipients in order to bring more stability to the product, has been accused, between march 2017 and April 2018, by some 31 000 patients suffering from headache, insomnia, dizziness, and so on, A study of pharmaco-epidemiology conducted by the Agency of the drug (MSNA) on more than two million patients concluded in June 2019 that the transition to the new formula of the Levothyrox did not cause “serious health problems”.
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The crisis of the Levothyrox, medication for thyroid
Levothyrox: end of the marketing of the old formula in September Levothyrox : more than 3300 complainants appealed against Merck Lévothyrox : the sick want an independent expertise on “impurities” inferred
In June 2020, more than 3,000 consumers of this medicine have obtained by calling the Lyon recognition of a lack of information of the German manufacturer Merck regarding the launch of the new formula, with a compensation of 1000 euros for moral damages.
