Published the 11.09.2017 at 14h31
The figure grows day by day. The number of patients who complain of side effects from the change of formula of the Levothyrox increases. According to the minister of Health, speaking this morning on RTL, 9, 000 cases of adverse effects have been reported in the MSNA (national security agency of the drug).
The health authorities had first reported of 1 500 and 5 000 cases related to the new formula of this drug administered in the treatment of disorders of the thyroid. “If you look at the surveys of pharmacovigilance and this dates back to the ground, we have 9,000 reports on the three million people who take in France Levothyrox “, explained Agnès Buzyn.
“Endangering the lives of others”
The new formula of this drug has been on the market since the end of march, and since then, some patients complain of side effects – headache, dizziness, cramps or hair loss. The format change has been requested by the MSNA in order to improve the stability of the drug at the time.
Complaint for “endangering the lives of others” have been filed by patients. The findings of the investigation of pharmacovigilance will be published in October. During a press conference, which was held on 6 September, the minister of Health has lamented a lack of information delivered to patients in advance of the change of formula.
Side effects predictable
In fact, because of the profile of this drug, therapeutic margin is very low, the risk of propagation of side effects was foreseeable : the determination of the Levothyrox is very accurate and a very slight change can induce these effects. This was also the case in the United States and in Belgium, where these two countries have changed the formula. The message has been transmitted to the French physicians via mail, but with the benefit of hindsight, more thrust would have had to be deployed, explained the minister.
However, it stated that tests had been carried out on the new tablets, and confirmed the absence of impurities. The patients are advised to consult their doctor in order to make them part of the side effects encountered. For patients who suffer from such effects, dosages, TSH should be carried out to possibly re-evaluate the dosage. On the other hand, the authorities insist on the importance of maintaining their treatment and not go back to the old formula. “These effects will fade in time,” said Agnes Buzyn.