Health Minister Agnes Buzyn announced on 15 September, this is now done
As of Monday morning, the pharmacists will be able to again order the older version of the drug to their wholesalers.
The drug will be called now more ‘Advise’ but ‘Euthyrox.
“It is the trade name of the drug in Germany and in many other countries,” explains the Merck laboratory Figaro. The drug, produced in the same factory as the former Levothyrox, will indeed be imported from Germany.
Total 90,000 boxes of 100 tablets will be made available to pharmacies. Until then, the advise was sold by box of 30 tablets in France. Patients who will prescribe the Euthyrox will have their treatment for three months. In a statement, the national order of pharmacists recalls that “it should be prescribed only as a last resort for patients who encounter lasting adverse effects with other drugs”.
Patients who wish to return to the old formula will have to first visit their doctor or their endocrinologist who will validate whether this decision. The drug will be accompanied by a notice translated into french by the pharmacist. “This temporary solution is that push the problem” Alain Delgutt, President of the central Council of the national order of pharmacists this return remains temporary because the old formula will be more manufactured from 201 8 in Germany. “There is a current to change the formula in Germany, registration indicates Merck.
” Little by little, the change will take place in all the countries where the drug is marketed. ” «This updated transitional provision responds to a one-time request, but in truth, it only just putting off the problem, says Alain Delgutt, President of the central Council of the national order of pharmacists. » In a few months, patients will have to change drug and find again the mix allowing the better hormonal balance. ” As of mid-October, another drug, L-Thyroxin Henning of the laboratory Sanofi will also be available. The princeps drug is marketed for many years in Germany, countries where the boxes will be imported. As for the Euthyrox, records translated into french will be given to patients by pharmacists. Subsequently, an application for authorisation for placing on the market of the laboratory will enable a sustainable marketing. The drug drinkable drops, made by the french laboratory Serb, remains reserved primarily for children under 8 years, for people who have swallowing disorders and in patients who have already had a prescription of this specialty before 31 August 2017. Retour on the criseEn March 2017, the Merck laboratory has ceased to market the original advise in favor of a drug ensuring stability of the active ingredient over time. Many patients (nearly 15,000 reports of side effects, according to Le Figaro, according to the Minister of health 9000) were surprised by side effects related to the change of formula. A petition seeking the return of the old formula launched late June on the internet has thus collected nearly 300,000 signatures. Several hypotheses have been advanced to explain the occurrence of these symptoms (disorders of heart rhythm, muscle cramps, intestinal problems, headaches, dizziness..
.. .). The new excipient – molecule that coats the active principle-, the quality of the drug, or even its long-term tolerance have in turn been questioned. ” Levothyrox: clues to understand the crisis on September 15, the Minister of health asked the safety of the drug (MSNA) Agency to make public the results of clinical trials and analyses. Total 3000 pages have been made online the day even. The reassuring data, according to the doctor and journalist Dominique Dupagne: “It appears from reading the details of the main bioequivalence study the new LEVOTHYROX is perfectly suited to the replacement of the old formula”.
So, the crisis could be explained by a temporary imbalance of thyroid hormones, especially since a very small change in dosage can destabilize this balance. But remember, the old formula had the distinction of not being stable enough: after 6 months, nearly one-third of the active ingredient (the hormone levothyroxine) disappeared. This means that the dose actually ingested by patients was not that shown on the box. After months, most were still managed to find this balance. Disturbed by the new balance formula, with more precise dosing.
Therefore, these patients should again stabilize their thyroid hormone balance. “For more information:” hypothyroidism, what is it? .