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After creating a health scandal, Levothyrox returns under a new formula . The new version of the drug will be distributed in France, and 20 other European countries, in 2019.
The Merck laboratory, which manufactures the drug against the thyroid, announced Thursday, July 26 that this new formula was validated July 18 last by the BFARM (the German Federal Institute for Medicines and Medical Devices) and received a "positive opinion" from the European health authorities .
In order to avoid the previous health crisis, the laboratory Merck says it has "already complied with all the mandatory steps required by the local health authorities to launch the new formula". In addition, he indicates that he will continue to "monitor and examine the experience of patients with the new formula in the markets on which it will be launched."
Health crises caused by the old formula
The same day, the Council of State rejected the request of patients to urgently restore the availability of the old formula. From the beginning of its marketing in spring 2017, the old formula of Levothyrox had created a health crisis .
Approximately 1,200 patients had filed a complaint against the Merck laboratory. They accused the drug of causing a wave of side effects: fatigue, headache, insomnia, dizziness, hair loss, joint and muscle pain .
Three reports of "pharmacovigilance" had been claimed by the French Medicines Agency (ANSM). All three had reached the same conclusion: adverse effects identical to those already known with the previous formula but in much greater numbers. An increase which had no explanation .
While it had the quasi-monopoly before the change of the formula, the laboratory must now face four new competitors for his medication: L-thyroxin Henning, Thyrofix, L-thyroxine SERB and TCAPS
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