This high-profile thyroid drug, which was due to end in September, is in fact renewed for the 75,000 patients who have not changed treatment.
Many patients are relieved by this news. According to a letter from the Ministry of Health distributed by a patient association, the old formula of the drug against hypothyroidism Levothyrox, which should normally stop at the end of September, will be available until the end of 2021. It is the fight of several associations which has among this extension.
For the latter, the new formula of Levothyrox marketed by the Merck laboratory since 2017 just like the other drugs on the market did not suit certain patients.
During a follow-up committee held on July 6 at the Ministry of Health, "The National Agency for the Safety of Medicines and Health Products is a French public establishment. Asked Merck laboratories to do everything possible to maintain the Euthyrox specialty in France beyond September 2020. (…) Merck laboratories responded favorably to this request. Thus, the maintenance of Euthyrox in France will continue in 2021 ", explains the General Directorate of health (DGS) in a letter dated Friday, circulated by the French Association of Thyroid Patients (AFMT). The Directorate General of Health has confirmed the sending of this letter, according to the France-Presse agency.
The Ministry of Health recalls that Euthyrox is a drug "initially intended for the Russian market, strictly corresponding to the old formula of the specialty Levothyrox, and subject to temporary importation;"
About 95,000 patients were still treated with this old formula in the first quarter of 2020, "or 3.1% of the 3 million patients treated with levothyroxine", the active ingredient of this drug, estimated the ministry in July.
"This extension of the distribution of Euthyrox will give the patients concerned additional time to initiate the change of treatment as soon as possible for a lasting therapeutic alternative", explains the DGS in its letter. For the AFMT, it is a "huge relief" for the patients concerned, who "were threatened to be suddenly deprived of the drug which suits them".
The AFMT, UPGCS and VST organizations had once again exposed their opposition to this judgment, and mentioned "the major health risk that there would be to implement such a substitution in the midst of Covid", with access to care still disturbed, relays AFP.
Concerning the new formula of Levothyrox, which modifies some of its excipients in order to bring more stability to the product, it was incriminated, between March 2017 and April 2018, by some 31,000 patients suffering from headaches, insomnia, or even dizziness.
More than 3,000 consumers of this drug thus obtained on appeal in Lyon, in June 2020, recognition of a lack of information from Merck about the launch of the new formula, with compensation of 1,000 euros at the title of moral damage.