The complaints of patients suffering from the side effects of the new formula of Levothyrox, a medicine to treat thyroid disorders, have been heard.
"I asked the drug safety agency (ANSM) to make sure that the old Levothyrox is accessible so that those who claim it can take it and it will be available in 15 days", announced the Minister of Solidarities and Health Agnès Buzyn at the microphone of France Inter this Friday, September 15.
A temporary return of the old formula of Levothyrox
However, it specifies, through a press release, that this return to the old formula is only "temporary" and will be "made available on medical prescription for patients with persistent adverse effects ". And to add that " new specialties of levothyroxine (active ingredient of the drug) will arrive within 4 weeks on the French market."
It will be "other brands, other drugs that will gradually allow patients to choose the one that suits them," she explains, knowing that the old Levothyrox should normally disappear because the laboratory should no longer produce it in the coming years. "
The complaints of associations and patients heard
"What matters is that patients have the choice to have products that are adapted to their feelings (...) I think it's important to hear the patient's complaint," the minister added. .
Last week, Agnès Buzyn had received patient associations and acknowledged "a lack of information on the change of formula".
She invited patients to find " the right dosage with the help of their doctor".
A statement reviewed and corrected this morning at France Inter: " What the doctors said was that the majority of side effects were related to the fact that this drug destabilized the hormonal balance of people and so it was enough to find the right dose but, in fact, there are patients who despite a good dosage continue to have side effects and these patients we hear them. "
In addition, she claims to have asked the National Agency for Safety of Health Products and Medicines "to make public the bioequivalence studies * that she conducted on the new formula", as well as the analyzes confirming the quality of the new formulation of Levothyrox, the available data on excipients and a list of their wide use in common drugs.
Finally, the minister undertakes to launch soon "a mission on the means of a better information of patients and health professionals on drugs."
What to reassure, for the moment, the three million people treated by Levothyrox.
* https://ansm.sante.fr/Mediatheque/Publications/Rapports-Syntheses-Medicaments#folder_110079