Lack of support for certain patients Presence of impurities, manufacturing problems… Many explanations are in turn put forward, most often by patient associations, anxious to understand the situation. Between March and November 2017, just over 17,300 patients reported adverse effects. We were completely helpless, ”says in 2020 to Figaro Béate Bartès, president of the association Living without thyroid. But three months after the arrival of the new tablets in French pharmacies, the system for monitoring adverse effects is racing: fatigue, dizziness, headaches, muscle pain, hair loss, suicidal thoughts… “From the month of April, we were overwhelmed with messages. Unacceptable for a drug that requires a fine dosage specific to each patient. With the old formula, the active ingredient deteriorated on contact with excipients. In March 2017, Merck put a new version of Levothyrox on the market, in accordance with a request made in 2012 by the National Medicines Safety Agency (ANSM). To read also Chronic fatigue, dry skin, intestinal disorders… What if it was hypothyroidism? Reminder of the facts. Which is not the opinion of some patients. “We consider not only that we have complied with the regulations, always with the approval of the authorities, but also that we have gone beyond what was imposed”, argues the lawyer. The debate will therefore focus on the communication plan that accompanied the arrival of the new Levothyrox formula. The investigating judge ruled out the most serious charges of prevention, namely homicide and involuntary injury as well as the endangerment of others, to retain only aggravated deception. “It is not the quality of the drug that is implicated, clarifies Mario Stasi, lawyer for the pharmaceutical firm. This molecule is taken daily by 2.3 million people in France to overcome the inability of their thyroid to produce levothyroxine, a hormone that plays a central role in the body. The French subsidiary of the German pharmaceutical company Merck announced on Wednesday morning its indictment for “aggravated deception” in the criminal investigation into the change in formula of the drug which, in 2017, had been followed by a wave of declaration of effects unprecedented undesirables. This is a new twist in the Levothyrox affair, which has hardly been talked about for several years. Justice will have to determine if there was a failure to inform patients during the change of formula in 2017. The manufacturer of this essential drug in hypothyroidism is indicted for “aggravated deception”.
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