After the ANSM’s indictment in the Levothyrox case, another relief for patient associations has been confirmed by the Ministry of Health: the distribution of the old Levothyrox formula will continue in France in 2023. “We have confirmed that the Merck laboratory guarantees the supply of the French market in specialty Euthyrox for the year 2023″, indicated this December 7, the general direction of health (DGS) to AFP.
“Imports will continue to come from production intended for the Russian market and will always correspond to the Euthyrox formula, strictly identical to the old formula of the Levothyrox specialty distributed in France until 2017”, specified the same source.
Levothyrox (initial formula) still available in 2023
The marketing of the old formula of Levothyrox was to stop at the end of September 2020. But, at the request of the French Medicines Agency (ANSM), the Merck laboratory extended until the end of 2023 the availability in France of this drug against hypothyroidism. A decision supported and awaited by several patient associations, dissatisfied with the new formula proposed since 2017. The list of levothyroxine-based medicines is downloadable from the ANSM website.
In France, just under 100,000 patients are treated with the old formula, imported since the end of 2017 under the name Euthyrox.
Update on the case: indictments of Merck and ANSM
The National Medicines and Health Products Agency (ANSM) been indicted today for “cheating” by the investigating judge in charge of the file of the new formula of Levothyrox. In a press release published Monday evening December 5, ANSM explains that she “will make her full contribution to the manifestation of the truth” but “firmly contests the reproaches made against her because no criminal offense has been committed.” She adds that she has always taken into consideration the difficulties encountered by some patients when switching to the new Levothyrox formula.
Contacted by Top Health, Anne-Catherine Colin-Chaulet, Founding President of the association Thyroid Alertwhich represents no less than 1,500 complainants, is delighted with this decision and to see the investigation progress. “It is a logical continuation after the examination of the Merck laboratory, she commented, now we have to go further and extend the offense to involuntary injury and homicide involuntary.”
On October 19, the French subsidiary of the German pharmaceutical company Merck announced in a press release its indictment for “aggravated deception” in the formula change file of the Levothyrox drug. A criminal investigation for aggravated deception, homicide and involuntary injuries was opened in 2018. The reason for this indictment? The “information procedures put in place at the time of the transition from the old to the new formula in 2017 of this drug prescribed against hyperthyroidism”.
Moreover, on the civilian side, Merk has already been convicted. The Court of Cassation had rejected last March the appeal of the group, condemned in 2020 to compensate more than 3,300 users who suffered from side effects following the change of formula. In its decision, the latter considered that “when the composition of a drug changes and this change in formula is not explicitly indicated in the leaflet, the manufacturer and the operator can be blamed for a lack of information “, can “cause moral harm“.
Many side effects after changing the formula of Levothyrox
The problem is that the change from the old formula to the new formula, without informing the patients, had not gone unnoticed. Indeed, from 2017, the side effects are multiplying:
- headache,
- diarrhoea,
- insomnia,
- dizziness,
- hair loss…
As a result, the new composition of the drug, modifying some of its excipients in order to provide more stability to the product, was incriminated, between March 2017 and April 2018, by some 31,000 patients.
[En vidéo] Levothyrox: a new health scandal?
