After months of investigation into the new formula of Levothyrox, the Medicines Agency (ANSM) concluded that it had not led to an increase in “serious health problems” and that it was of “good quality”.
No increase in “serious health problems”. This is the conclusion reached by the Ministry of Health on the new Levothyrox formula. This follows months of investigations by the Medicines Agency (ANSM), with many thyroid patients complaining of adverse side effects after taking the new drug introduced by the Merck laboratory in 2017. term of analysis, the agency also confirmed “the good quality of the new formula of Levothyrox”.
The study scrutinized the number of deaths, hospitalizations and absences from work of at least seven days between April and June 2017, i.e. after the arrival of the drug on the market, by comparing them to the period from April to June 2016. Result: the data does not show an increase in serious health problems with the new Levothyrox, assures the ANSM. The latter, however, recognizes a “significant increase” in consultations among patients who used the new formula in 2017. “It particularly concerned appeals to general practitioners and endocrinologists and focused on the period from August to October 2017″, details the agency, reporting 360,000 additional consultations, or +2%.
Unsurprisingly, the French Association of Thyroid Patients (AFMT) immediately challenged the results of this report. In view of the unexplained side effects reported by many patients (cramps, headaches, dizziness, hair loss, etc.), the absence of abnormalities in the analyzes “cannot in any way guarantee the quality” of the drug, ensures the association.
Request for cancellation of the patent for the new formula of Levothyrox
The study may well show that “the switch to the new formula did not trigger a wave of deaths”, “no one had ever claimed it”, adds the AFMT, explaining that around ten additional deaths compared to the number predictable deaths “would not be statistically significant but nonetheless real”. Moreover, at the end of the period analyzed (end of 2017), more than 15% of patients included in the study had abandoned the new formula for an alternative. “If they did, it’s because they weren’t satisfied with the new formula,” insists the AFMT. Indeed, according to official figures from pharmacies, the number of patients who opted for a treatment other than Levothyrox continued to climb in 2018.
A week after the opening of the civil lawsuit filed by 4113 consumers against Merck in early December, a hundred plaintiffs have also filed a summons to demand the cancellation of the new Levothyrox formula. The summons challenges the patent for “insufficient disclosure of the invention, lack of novelty and lack of inventive step”, explains the AFMT on its website. The plaintiffs are asking for “the cancellation of the French part of the patent”, according to their lawyer Anne-Catherine Colin-Chauley, because “Merck is seeking to extend its new formula to all of Europe and the risk would be that patients would no longer be able to supply abroad, in Italy, Belgium or Germany”.
Attacked, the laboratory retorted that it “does not understand the purpose of the action taken against its patent” which “in no way aims to preserve any market share”. “Merck has filed a patent on the new formula because it is the only way to protect the results of internal research”, continues the group, recalling in passing that “more than 30 million euros” have been invested in this new formula.
