Levothyrox: the new formula did not cause "serious problems" according to the ANSM

According to a report from the French Medicines Agency (ANSM), Levothyrox's new formula has not provoked "serious health problems" or hospitalizations, despite the repeated denunciations of thousands of users.

New rebound in the case of Levothyrox.

While thousands of people have been denouncing the new formula of the antithyroid drug since it was launched in the spring of 2017 by the Merck laboratory, the National Medicines Agency (ANSM) has published the final report of the study contradicting patients' associations. According to his findings, this new Levothyrox formula did not cause "serious health problems" leading to death, hospitalization or work stoppages, including in patients who switched to substitution treatment.

Serious side effects according to the patients

The Levotyrox case began in February 2017, when the drug formula was changed. This change involved the replacement of lactose, which coated the thyroid hormone levothyroxine to form a tablet with mannitol. This change had been requested by the French Medicines Agency (ANSM) to ensure the stability of the product over time, which was not the case with the old formula.

But the patients have experienced unwanted side effects. Of the 2.3 million patients treated in France, 17,000 cases of side effects were identified. A total of 5 062 adverse reactions were classified as serious and 14 deaths were recorded by the ANSM, although a direct link with the new formula can be formally established.

The report therefore confirms the absence of a causal link between the new formula and the reported deaths. In total, more than 2 million patients were interviewed by the ANSM for 6 months. The objective of the report: to compare the number of deaths, hospitalizations and work stoppages of at least seven days, as well as the consumption of drugs between April and June 2017 (new formula, or NF) in the period April to June 2016 for patients taking the old formula (AF).

360,000 additional consultations

In addition to the absence of "serious health problems", the report of the Agence du médicament shows that patients have not consumed more drugs such as painkillers, anti-vertigo drugs, corticosteroids, antimigraine agents or antidiarrheals after their passage. to the new formula. On the other hand, the report points to a "clear increase" in medical consultations, ie 360,000 additional consultations, in particular GPs and endocrinologists, focused on the period from August to October 2017. It also notes an increase in some medications such as benzodiazepines, usually taken for sleep or anxiety.

No increase in the risk of death

According to the report, the risk of death does not differ statistically between patients who took the old formula and those who took the new one. "6,355 in the NF group - new formula (0.6%) and 6,387 in the AF group - old formula (0.6%)", notes the ANSM.

According to Dr. Rosemary Dray-Spira, epidemiologist, co-author of the report, additional results confirm the main results that are not in favor of a specific toxicity of the new formula (NF) of Levothyrox. Further analysis concerns the group of patients (18%) who stopped the NF at the end of 2017 to take another medicine such as L-Thyroxin Henning, Thyrofix, Tcap, available from October 2017. "At home, either, 'There was no more hospitalization,' notes Rosemary Dray-Spira. "On the other hand, they consumed a few more drugs, but in proportions that remain modest." About 2% of patients stopped the new Levothyrox formula, with a stop in their reimbursements for thyroid hormone therapy.

Video: Mayo Clinic Minute: Levothyroxine overload? (November 2019).