The distribution of the old form of this drug for hypothyroidism, which had to be suspended in September after criticism of the new formula, has been extended. AND
The distribution of the old form of this drug for hypothyroidism, which had to be suspended in September after criticism of the new formula, has been extended.
A change and relief for tens of thousands of patients. The old formula of the antihypothyroid drug Levothyrox, whose distribution was supposed to stop at the end of September, will finally be available at the end of 2021, according to a letter from the Ministry of Health shared by a patient association. Several associations have requested this extension, arguing that neither the new formulation of Levothyrox, which Merck has been marketing since 2017, nor any other comparable drug recently launched on the market, is suitable for some patients.
At the end of the follow-up committee held on July 6 at the Ministry of Health, “MAN asked Merck to do everything possible to keep specialized Euthyrox in France after September 2020. (…) Merck laboratories responded positively to this request. Therefore, the maintenance of Euthyrox in France will continue there in 2021”, said the General Directorate of Health (DGS) in a letter dated Friday, published by the French Association of Thyroid Patients (AFMT). Contacted by AFP, the DGS confirmed the sending of this letter.
95,000 patients treated with the old formula
Euthyrox is a drug initially intended for the Russian market, it strictly corresponds to the old formula of the Levothyrox specialty and is subject to temporary importation,” recalls the ministry. In the first quarter of 2020, some 95,000 patients were still being treated with the old formula, “which is 3.1% of 3 million patients treated with levothyroxine”, the active ingredient in this drug, the ministry estimated in July.
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“This expansion of Euthyrox distribution will offer affected patients additional time to initiate a change of treatment to a perennial therapeutic alternative as soon as possible,” the DGS wrote in an email. The announcement was described by the AFMT as a “tremendous relief” for the patients involved, who “were at risk of suddenly being deprived of the medicine that works for them.”
According to the association, this is a “radical change in attitude” of the health authorities, since the ministry, at the end of the control commission on July 6, marked the end of the distribution of Eutirox in September as “irrevocable ” and Referred only to the need to “support the judgment on the distribution of this drug.”
Access to care continues to be disrupted
During the follow-up commission, the AFMT, UPGCS and VST associations reiterated their opposition to this sentence and cited “the great health risk that would exist with the application of such a substitute (editor’s note: treatment) in a period full of Covid”, with access to medical care and more disturbed. According to the AFMT, the DGS explained that this change was the “situation on the Covid front” and Merck’s delay in switching to the new Levothyrox formulation, especially in Russia.
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Between March 2017 and April 2018, the new formulation of Levothyroxa, modifying some of its excipients to guarantee greater stability of the product, accused nearly 31,000 patients suffering from headaches, insomnia, dizziness, etc., a pharmacoepidemiological study carried out by The Medications Agency (MSNA) in more than two million patients concluded in June 2019 that switching to the new Levothyrox formulation did not cause “serious health problems.”
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The Levothyrox crisis, the thyroid medication
Levothyrox: Old Formula End Of Marketing In September Levothyrox: More Than 3,300 Whistleblowers File Complaint Against Merck Lévothyrox: Patients Want Independent Expertise On “Impurities”
In June 2020, more than 3,000 consumers of this drug received a summons in Lyon to admit that the German manufacturer Merck had not been informed of the launch of the new formula, with compensation of 1,000 euros for non-material damage.
Date Updated: August 11, 2020, 2:58 PM
Categories: Optical Illusion
Source: newstars.edu.vn