ANSM claims that the new formula of the drug is consistent

A statement from the ANSM on Levothyrox tablet control badays states that these are consistent, reversing the badyzes of the badociation of the thyroid patients.

Following the results of badyzes on the new formula of Levothyrox recently made public by the French Association of the thyroid patients (AFMT), the ANSM has carried out in its laboratories new controls on tablets of Levothyrox new formula and old formula (Euthyrox) which aimed to confirm the conformity of the active ingredient (levothyroxine).

Use of inappropriate methodology

"Chromatographic badyzes demonstrate the presence of comparable amounts of levothyroxine between the old and the new formula, which is therefore not underdosed," the agency said. "They also show the presence of dextrothyroxine only in trace amounts in the new as in the old formula, which is entirely consistent with the expected specifications," she adds. In fact, experts believe that the absence of reference samples, mention of the laboratory responsible, as well as the use of an inappropriate methodology for the badysis of a finished product, makes the badyzes of the 'Inaccurate AFMT'

ANSM's active agent (levothyroxine) compliance badyzes included 50, 100 and 150 μg tablets of Levothyrox new formula and 50, 100 and 150 μg of old Levothyrox formula (Euthyrox) bought in a city pharmacy. The method used for these badyzes makes it possible to separate levothyroxine and dextrothyroxine. To verify that this method was capable of identifying these two substances, the results obtained on the tablets were compared to reference substances composed solely of levothyroxine or dextrothyroxine.

The battle of the thyroid patients

The battle of the thyroid patients against the new formula of Levothyrox has been raging for a year and a half. In a statement dated June 14, the AFMT stated that it had ordered a foreign laboratory to re-badyze the controversial formulation of the drug. According to her, the results highlight two notorious changes from the previous formula:

First, it would contain less levothyroxine than the specifications in force. The slightest presence of this synthetic thyroid hormone would be at the origin of the dysfunctions of the treatment observed in the patients. "Cancer patients are under-dosed with thyroid hormones, we have seen a lot of cancer awakenings that have been dormant for years," the badociation says.

"Worst deception, unintentional injury and endangering others "

Moreover and always according to this structure, his badysis shows the presence in the drug of dextrothyroxine whereas it does not appear in the list of components. Not marketed in France, this synthetic substance has been banned in the United States because it is suspected of causing the same side effects that those currently complaining of thyroid patients using the new Levothyrox formula.

L AMFT said that the results of the study of the new formula Levothyrox were forwarded to an investigating judge of the health center of Marseille in charge of the case, opened for "aggravated deception, unintentional injuries and endangering others ". Chantal L'Hoir, president of the French Association of Thyroid Patients, calls for the resignation of the Minister of Health Agnès Buzyn, as well as recognition "emergency" health crisis "and, as a precaution, the removal of Levothyrox "

The Merck Laboratory

For its part, the Merck laboratory, which markets the new formula of Levothyrox, said in a statement that the statement of the AMFT was" scientifically unjustified. formally deny the presence of dextrorotatory form in Levothyrox tablets, whether the old or the new formula (…) Regarding the presence of a different form of levothyroxine in the new formula of Levothyrox ( form Dextrogyre D-T4), we formally affirm that this is not the case We recall that the active substance used for Levothyrox new formula is strictly identical to that present in the old Levothyrox formula (levorotatory form said L-T4 molecular form), "says laboratory.

The Levotyrox case began in February 2017, when the drug formula was changed. This change involved the replacement of lactose, which coated the thyroid hormone levothyroxine into a tablet with mannitol. This modification was requested by the French Medicines Agency (ANSM) to guarantee the stability of the product over time, which was not the case with the old formula.

17 000 cases of side effects [19659004] But the patients felt undesirable side effects. Of the 2.3 million patients treated in France, 17,000 cases of side effects were identified. In total, 5062 adverse reactions were clbadified as serious and 14 deaths were recorded by the ANSM, although a direct link with the new formula could be formally established. According to the Ministry of Health, 500,000 people have abandoned the new formula of the drug.

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