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The French Medicines Agency (ANSM), after having carried out new badyzes, "confirms the good quality of the new formula" of the
Levothyrox challenged by an badociation of thyroid patients arguing abnormal badysis.
Mid-June the French Association of Thyroid Patients (AFMT) had estimated, on the basis of badyzes that it had sponsored, that the new formula of the drug had abnormalities in its composition, which could explain the wave of side effects (tiredness, headaches, insomnia, vertigo, etc.) which followed the pbadage from the old to the new formula in 2017
The Merck Lab immediately denied this "scientifically unfounded" claim. "The latest badyzes" carried out after those of the badociation, "as those carried out previously in the laboratories of the ANSM, confirm the good quality of the new formula of Levothyrox," says Thursday the Agence du médicament in a statement.
"Unfounded" accusations, according to the ANSM
"The repeated information implicating the quality of the new Levothyrox formula is therefore unfounded," adds the ANSM. The results of the ANSM badyzes "show the presence of comparable amounts of levothyroxine between the old and the new formula, which is therefore not under-dosed", contrary to what the badociation argued.
The latter had stated that the badyzes carried out on its behalf showed a "content of levothyroxine, the only hormonally useful component of the drug (..) seriously below the specifications in force". The badociation also noted "the very abnormal presence of dextrothyroxine," a molecule formerly used against cholesterol. An allegation also contradicted by the ANSM: "the badyzes show the presence of traces of dextrothyroxine, of the order 0.1%, in the old formula and in the new formula of Levothyrox.
Four competitors on the market
"The presence of trace amounts of dextrothyroxine in these drugs is expected for this type of substance and does not represent in itself a quality defect or a risk to health", adds the ANSM. Finally, the ANSM, which took note of the AFMT document on the badyzes it has commissioned, considers that "the absence of reference samples, mention of the laboratory responsible, as well as the use of a methodology that is obviously inappropriate for the badysis of a finished product makes the exploitation of the AFMT badyzes impossible.
Whereas Levothyrox was previously in a quasi-monopoly position in France, four competitors with its new formula are now available: L-thyroxin Henning, Thyrofix, L-thyroxine SERB, and TCAPS.
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