The Agence du médicament confirms the good quality of the new Levothyrox

Is the new formulation of Levothyrox not yet available? the cause of the wave of adverse reactions that followed his arrival in pharmacies in March 2017? No, according to the National Agency for Drug Safety (ANSM), which published Friday the results of new badyzes. These, "like those carried out previously in the laboratories of the ANSM, confirm the good quality of the new formula of Levothyrox", indicated the Agency in a communiqué.

In September 2017, then in January 2018, she had already sifted the new formula to ensure that the composition of this drug taken daily by three million French was consistent. The results revealed that the content of the active ingredient – the levothyroxine hormone – and excipients was consistent with that displayed by the German laboratory Merck. On the other hand, the Agency detected the presence of trace metals in both old and new tablets. But this detection "does not represent in itself a defect of quality nor a health risk insofar as the concentrations are lower than the safety thresholds […]", however had specified the ANSM.

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The underdosing is not confirmed

This time, the goal was to verify that the new tablets were not under-dosed with levothyroxine (the active ingredient), a hypothesis raised in mid-June by the French Association of Thyroid Patients (AFMT). After having three tablets badyzed by a foreign laboratory, the AFMT had indeed claimed that those from a box of the new formula did not contain the right amount of active ingredient, unlike the tablet of the old formula. On the other hand, they included dextrothyroxine, a molecule chemically very close to levothyroxine, but which does not have the same effect in the body.

Problem: The badociation refused to publish the raw results and the method used by the laboratory. Moreover, the sample badyzed (only 3 tablets) did not make it possible to generalize these results. With the new badysis of the Agence du médicament, this trail seems to be closing. "The badyzes show the presence of traces of dextrothyroxine, of the order of 0.1%, in the old formula and in the new formula of Levothyrox," says the Agency. An expected discovery, which "does not represent in itself a quality defect or a risk to health", according to the ANSM. On the side of the health authorities, the debate seems closed: "The repeated information implicating the quality of the new formula of Levothyrox are therefore unfounded."

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Decrease in the number of reports

Several avenues have been put forward to explain the approximately 17,300 cases of adverse reactions reported to the health authorities between March 2017 and January 2018. Was the excipient of the new formula available? to change the effect of the active ingredient in the body? Has the new, more stable formula changed the dosages? Has the very high profile of the case contributed to the proliferation of reports of side effects? For now, none has been retained.

It would be interesting to know how many of these people have improved and how much has been done with other levothyroxine drugs. In a statement issued Friday night, the ANSM has in any case indicated that the number of reports had decreased sharply.