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The Merck laboratory plans to launch the new formula Levothyrox in 21 countries of the European Union from 2019, after a " positive opinion " of European health authorities, he said Thursday, July 26, 2018. " The European procedure for in-depth evaluation has resulted in a positive opinion for the introduction of the new Levothyrox formula in the 21 member states concerned ," the statement said in a statement. German laboratory
SUMMARY OF THE LEVOTHYROX CASE . The new formula Levothyrox was claimed by the National Agency for Drug Safety (ANSM) at the German laboratory Merck in 2012 to make the product more stable over time. The change does not concern the active ingredient, levothyroxine, but on other substances excipients: lactose has been replaced by mannitol and citric acid. Nearly 31,000 patients (out of about 3 million taking the drug) however quickly complained of side effects. Faced with their anger, the health authorities tried to provide other treatments, while the Levothyrox was in a situation of near-monopoly. 1,200 disgruntled patients have also filed several lawsuits for aggravated deception, unintentional injury and endangering others. The Council of State also rejected Thursday, July 26, 2018 the request for patients who urgently requested measures to ensure the availability of the old formula.
Adverse effects of known nature, but unexplained frequency
Since the beginning of the health crisis it has caused, the new Levothyrox formula has been the subject of three "pharmacovigilance" reports in France, at the request of the French Medicines Agency (ANSM). All three have reached the same conclusion: the undesirable effects are identical to those already known with the old formula but in much greater numbers, and there is no reason to explain this increase. Merck said to have " already complied with all the mandatory steps required by the local health authorities to launch the new formula ". " Several official reports of expertise published these days allow (…) to comfort the 2.5 million French patients who, for over a year, have found their thyroid balance thanks to" the new formula, comments Merck.
ALTERNATIVES . Of the 3 million patients who were on the old formula Levothyrox, difficult to know how much have pbaded to one of the 4 alternatives now on the market (L-Thyroxin Henning, Thyrofix, L-thyroxine SERB and TCAPS). More than 700,000 patients are under these alternatives according to the ANSM, without being able to say what is the share of transfers since Levothyrox and what is the share of new patients. For the Merck laboratory, they are half a million patients to have dropped the Levothyrox for a competitor, while they would be 1 million according to the badociation Living without Thyroid.
Launch in 2019 in 21 countries of the EU out of 28
According to the laboratory, the positive opinion was delivered on 18 July by BfArM, the German Federal Institute for Medicines and Medical Devices. He had been " responsible for the process of approval and verification of data " by the European Medicines Agency (EMA). " Each of the 21 countries will now be able to approve and implement this recommendation at the national level ," said Merck. This European procedure concerns 21 of the 28 EU countries. " After the respective national authorizations, we plan to launch the new formulation (…) in the 21 countries from 2019 ", added Merck, according to which " the launch in Germany is planned for the first semester "
A decision that the badociation Living without Thyroid does not include: " nobody wonders about the reasons for the problems encountered in France ??? " s she queries in a Facebook post. " Merck had to be VERY persuasive in explaining that all this was only a nocebo effect and a collective hysteria of French patients ," she finally insinuates. For its part, "Merck will continue to monitor and examine the experience of patients with the new formula in the markets on which it will be launched" badured the laboratory.
With AFP
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