The new formula Levothyrox has not finished running ink. Last rebound in this case that has lasted for more than a year, the results of an independent study conducted by an association of patients, whose results are puzzling.

According to the French Association of Thyroid Patients (AFMT), which announced Thursday, June 14 have ordered an analysis at a foreign laboratory to determine the composition of the new formula of Levothyrox Merck, the new Levothyrox would be under- dosed with levothyroxine, the active substance in this medicine for the thyroid patient. "The results, especially the levothyroxine content, are normal for AF (old formula), but conversely, for both lots of 'NF' (new formula), the levothyroxine content is seriously inferior to the specifications in force ", indicates the press release * written by the association.

Research also reveals the presence of dextrothyroxine in the drug. According to the AFMT, this molecule does not appear on the list of treatment components. Not marketed in France, it was withdrawn from sale in the United States, because of side effects such as cramps, vertigo or even hair loss (similar to the symptoms felt by patients with thyroid ).

The study was sent to a judge of instruction

The investigating magistrate of the Marseilles health center in charge of the criminal investigation against the Merck laboratory for "aggravated deception, involuntary injuries and endangering others" were informed of the results of the study, which did not could not be transmitted to us.

The association now calls the National Agency for Drug Safety to bounce back on these results to affirm or refute them. "It is the responsibility of the ANSM, whose mission is to urgently assess, by independent laboratories, a significant number of samples taken from the boxes of 'NF' batches used by patient-victims and comparison of batches of 'AF' ", calls the AFMT.

The association then adds: "The Ministry of Health and the ANSM must come out of their inertia, conduct all necessary investigations in an emergency, and take their responsibilities to ensure the safety of our fellow citizens and to expose the responsibilities undertaken. "

A study "scientifically unfounded" according to Merck

The AFMT remains aware of the fact that these results can not draw 100% certainty, but specifies that this first research should be pursued by more comprehensive studies. "At this stage, our association does not claim, in a single study, to have indisputable 'proof', but an important new fact, because if these results were confirmed, as one might think, they could constitute a rational explanation to this crisis, of always unknown origin ", justifies the association.

The ANSM has not yet expressed itself on the subject, and does not wish to comment "a study that she did not see", according to our colleagues from France Info. In a statement, the Merck laboratory said that the study of the AFMT was "scientifically unfounded".

Since the Merck Levothyrox formula change in March 2017, three million patients have complained of side effects, and 500,000 of them have dropped their treatment. Some have gone back and forth to find the old medicine, the others have opted for new treatments put on the market at the end of 2017 by competing laboratories.

* www.asso-malades-thyroide.fr/wordpress/index.php/2018/06/14/crisis-sanitaire-du-levothyrox-can-be-finally-a-reason-explication/