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In France, the first country where it was introduced in the spring of 2017, the new formula of this drug indicated in the treatment of hypothyroidism caused a sharp controversy.
The Merck laboratory plans to launch the new Levothyrox's formula in 21 countries of the EU from 2019, after a "positive opinion" of European health authorities, he announced Thursday. "The European in-depth evaluation procedure has resulted in a positive opinion for the introduction of the new Levothyrox formula in the 21 Member States concerned," the German laboratory said in a statement.
According to the laboratory, Positive opinion was delivered on July 18 by the BfArM, the German Federal Institute for Medicines and Medical Devices. He had been "in charge of the approval process and verification of data" by the European Medicines Agency (EMA). "National approvals will be issued as a result of this recommendation," said Merck. This European procedure concerns 21 of the 28 countries of the EU
»READ ALSO – Four misconceptions about Levothyrox
A change that went wrong
In France, the first country where it was introduced in the spring of 2017, the new formula of this drug indicated in the treatment of hypothyroidism sparked a heated controversy. Patients have accused him of causing a wave of side effects (fatigue, headaches, insomnia, dizziness, joint and muscle pain and hair loss). The case is the subject of several legal proceedings: about 1,200 disgruntled patients filed a complaint against Merck. The Council of State also rejected on Thursday the demand for patients who urgently requested measures to ensure the availability of the old formula.
Since the beginning of the health crisis it provoked, the new formula of Levothyrox has been the subject of three "pharmacovigilance" reports in France, at the request of the French Medicines Agency (ANSM). All have reached the same conclusion: the adverse effects are identical to those already known with the old formula but in much greater numbers, and nothing can explain this increase.
"Merck will continue to monitor and review the patient experience with the new formula in the markets it will be launched on," said the lab, which said it has "already complied with all mandatory steps required by local health authorities to launch the new formula ".
Before the change of formula, Levothyrox was in a quasi-monopoly situation in France. Today, four competitors with its new formula are available: L-Thyroxin Henning, Thyrofix, L-thyroxine SERB and TCAPS.
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