Levothyrox : Agnès Buzyn recognizes a crisis situation

PIERRE VILLARD/SIPA

Published the 07.09.2017 at 08h02

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Lévothyroxeffets side

The ministry of Health is out of his silence. While thousands of people complain of side effects, sometimes very disabling, since the change of formula of Levothyrox, the health authorities held a press conference on Wednesday after meeting with the associations of patients. Were notably present the minister of Health, Agnes Buzyn, and the director of the national security Agency of the drug, Dominique Martin.

The minister has recognized a situation of “crisis” related to the change in formula of this treatment administered in the thyroid disorder, while refusing to characterize the situation of ” scandal sanitary.”
“These patients have felt real side effects which have greatly hampered these last few months, she said. These effects are notable but they do not put in danger the life of people. It is important that patients talk to their doctor, but they do not stop their treatment because then, they would be in danger.”

“The effects will fade”

The minister has referred to two axes to respond to the suffering of these patients. The first, concerning the ” short-term solutions “, is to recognize these side effects, to endorse the fact that it is not a fad of patients dissatisfied, an effect purely psychological.
Agnès Buzyn calls each patient experiencing adverse effects consult a health care professional to explore treatments to reduce the symptoms associated with the new formula.

“For many, the side effects will fade with time,” she added, citing the example of the United States, where the drug has also changed in form there are a dozen years, and have led to a multiplication of adverse effects, during a limited period of time. The emergence of these effects is related to the profile of the drug, said therapeutic range low – dosage should not be subjected to any variation. Tests conducted by the MSNA have validated the bioequivalence and the lack of impurity in the new formula, added the minister.

There is no question of a return to the old formula, as claimed in the petition on the subject. In fact, ” the formula has been changed because the old was not stable. Eventually, the patient will perceive a great benefit because the dosage will be better balanced “.

Target the information and inform the patients

The MAN has launched a study of pharmacovigilance in order to collect all of the side effects. The Web site dedicated to adverse drug effects identified 5000 notifications on Levothyrox, but ” no serious effects “, says the agency. Fifty cases of hypothyroidism or hyperthyroidism was induced by the new formula and confirmed by assays TSH were detected. The first results of the study are expected for the month of October.

The longer-term solutions reside in the provision of a generic on the market, in order to allow patients to receive alternative therapy – there is currently only a single formula. The MAN ” has been in contact with the laboratories in this direction “.
In addition, the minister announced the launch of a mission to improve information to patients, through ” personalized information “.

Because of this point of view, the phenomenon Levothyrox is a textbook case : letters were sent to the physicians for the prevention of the change of formula, but as so often, the message is not passed on from many patients. The mission will aim to overcome this lack of communication that we are constantly on the affairs related to drugs.

Three million people take Levothyrox in France. The multiplication of the number of side-effects was indeed foreseeable, but no system has been deployed to accompany the patient in advance of the change of formula. This ” default cover “, the minister of Health has acknowledged. Will there be lessons ?