HEALTH – The old formula of the hypothyroid drug Levothyrox, whose distribution was due 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 distributed by a patients association on Monday, August 1.
Several associations called for this extension, believing that neither the new Levothyrox formula marketed by the Merck laboratory since 2017 nor any of the other comparable drugs recently on the market were suitable for certain patients.
At the end of a monitoring committee held on July 6 at the Ministry of Health, “the ANSM asked the Merck laboratories to do everything possible to maintain the Euthyrox specialty in France beyond September 2020. (.. .) Merck laboratories have responded favorably to this request. Thus, the maintenance of Euthyrox in France will continue in 2021 ”, explains the Directorate General for Health (DGS) in a letter dated Friday, distributed by the French Association of Thyroid Patients (AFMT). Together with AFP, the DGS confirmed the sending of this letter.
“Extra time” to change treatment
Euthyrox is a drug “initially destined for the Russian market, which strictly corresponds to the old formula of the Levothyrox specialty, and is subject to temporary importation,” the ministry recalls.
In the first quarter of 2020, some 95,000 patients were still being treated with this old formula, “or 3.1% of the 3 million patients treated with levothyroxine,” the active principle of this drug, the ministry estimated in July.
“This expansion of the distribution of Euthyrox will offer affected patients additional time to start the change of treatment as soon as possible for a durable therapeutic alternative,” estimates the DGS in its letter.
“A great relief”
An advertisement described by the AFMT of “immense relief” for the affected patients, who “were threatened with being brutally deprived of the drug that suits them best.”
According to the association, this is a “radical change of position” of the health authorities, because at the end of the monitoring committee on July 6, the ministry described the end of the distribution of Euthyrox in September as “Irrevocable” and only mentioned the need “to accompany the interruption of the distribution of this medicine.”
During this monitoring committee, the AFMT, UPGCS and VST associations reiterated their opposition to this ruling, and mentioned “the greater risk to health that would have to implement such a substitution (treatment, editor’s note) in the middle of the Covid period”, with access to healthcare still disrupted.
According to the AFMT, the DGS explained this change to them because of “the situation on the Covid front” and Merck’s delay in switching to the new Levothyrox formula, particularly in Russia.
Side effects but not “serious health problems”
The new Levothyrox formula, modifying some of its excipients to provide more stability to the product, was incriminated, between March 2017 and April 2018, by some 31,000 patients who suffered from headaches, insomnia, dizziness, etc.
A pharmacoepidemiology study conducted by the French Medicines Agency (ANSM) in more than two million patients concluded in June 2019 that the switch to the new Levothyrox formula had not caused “serious health problems.”
In June 2020, more than 3,000 consumers of this drug obtained on appeal in Lyon the recognition of the lack of information from the German manufacturer Merck on the launch of the new formula, with compensation of 1,000 euros for non-pecuniary damage.
See also in The HuffPost: Levothyrox: The thyroid, what is it? How does it work wrong?