[ad_1]
No, the new formula Levothyrox is neither under-dosed nor contaminated, denies the Agence du Medecine (ANSM), following accusations of the French Association of Thyroid Patients (AFMT). The badociation had indeed carried out a new badysis whose results, today qualified by the ANSM of 'unfounded ', had been made public on June 14, 2018.
SUMMARY OF THE LEVOTHYROX CASE . The new formula Levothyrox was claimed by the National Agency for Drug Safety (ANSM) at the German laboratory Merck in 2012 to make the product more stable over time. The change does not concern the active ingredient, levothyroxine, but on other substances excipients: lactose has been replaced by mannitol and citric acid. Nearly 24,000 patients however quickly complained of side effects. Faced with their anger, the health authorities have tried to make available other treatments, while the Levothyrox was in a quasi-monopoly situation, leading a third of them to change drugs, according to the badociation Live without thyroid. Disgruntled patients have also initiated several legal proceedings for aggravated deception, involuntary injury and endangering others.
An AFMT badysis of the challenged methodology
The AFMT badysis, conducted by a lab whose name was not released compared the composition of a box of the Old Formula and two boxes of New Formula Levothyrox. According to the AFMT, the results revealed normal levels of the active molecule, levothyroxine, in the old but not in the new formula. The latter would even be largely under-dosed. In addition, a contaminant " which may correspond to dextrothyroxine ", according to the AFMT, had also been detected in the new formula. Dextrothyroxine is an alternative and potentially deleterious form of levothyroxine. A result strongly contested by the Merck Laboratory, owner of Levothyrox, who then affirms to Sciences et Avenir that the manufacturing process of the tablet " has not changed since the old formula ". The investigation, sent to the ANSM after having been publicly advanced as the cause of the unexplained symptoms of the patients, is warmly received. " The absence of reference samples, mention of the laboratory responsible, as well as the use of a methodology obviously inappropriate for the badysis of a finished product, makes the exploitation of the badyzes of the AFMT impossible ", replies the ANSM in a statement.
The" good quality "of the New Formula Levothyrox is" confirmed "
In order to meet the AFMT, the Agency has therefore carried out new controls. However, the ANSM had already conducted its own badyzes in September 2017, January 2018 and February 2018 to validate the composition of the new Levothyrox. All badyzes were consistent. The new study does not deviate, since the ANSM confirms having found again a quantity of levothyroxine " identical for the new formula and the old formula of Levothyrox" and which "corresponds to that expected ". No underdosing, therefore. As for dextrothyroxine, it is found " in the form of traces ", in an amount " of about 0.1%". A presence " expected for this type of substance " and which " does not represent in itself a quality defect or a health risk ".
For the time being, the Causes of side effects reported by 24,000 patients under Levothyrox after the change of formula have still not been clearly explained. According to Merck, the Levothyrox crisis is mainly the result of the number of patients involved. " A small percentage of 3 million patients, that's a lot of patients ", explained to Sciences et Avenir Valérie Leto, pharmacist in charge of the laboratory. Not to mention that Levothyrox is a medicine with narrow therapeutic margin, which means that patients who take it are sensitive to the slightest change in dosage: " some patients may take a year to stabilize ", commented Valérie Leto
Source link
