Agnès Buzyn had promised mid-September: the old formula of Levothyrox is back on Tuesday, October 2 in pharmacies, with 90,000 treatments in the form of quarterly packaging.
A particular order required
"Since this specialty is only available for a limited duration and quantities, its prescription is not recommended.If a prescription must be made, it must imperatively be after September 14, 2017 and specifically mention the specialty" Euthyrox "to be able to give place to dispensing in pharmacy, "said an information point of the National Agency for Safety of Health Products and Medicines (ANSM) *.
Received Tuesday, September 26 by RMC, the Minister of Solidarity and Health said that this old version would be reserved "only to patients who have not been able to get used to the new version and feel side effects very debilitating" and invite those who support it not to change it.
A diversification of the offer of treatments proposed from mid-October
In addition, Agnès Buzyn promises a "diversification of supply" to end the monopoly on this drug "from mid-October".
"The important thing is that patients have the choice (...) I can understand their distress (...) We have made sure there are different offers of medicines for thyroid disorders. They are already available in Europe and will arrive on the French market, which will allow people to find the formula that suits them, "she adds.
This is the L-Thyroxine from the Serb laboratory (oral solution in drops), whose production has been increased. The ANSM reminds that "its use should be reserved primarily for children under 8 years, people who have swallowing disorders and patients who have already had a prescription of this specialty before August 31, 2017."
The other alternative is Sanofi's L-Thyroxin Henning (tablet).
"This brand-name drug has been on the market for many years in Germany, the boxes will be imported from Germany, the French-translated leaflets will be given to patients by pharmacists, and a marketing authorization application from the laboratory will follow. will allow a sustainable commercialization ", details the ANSM.
An information mission launched to improve support for patients
According to Agnès Buzyn, the "crisis" around Levothyrox stems from a lack of information for patients and an "undervaluation" by doctors and pharmacists, who "probably have not listened enough to the distress of patients. patients who said they felt side effects. "
A situation that motivated the minister to launch a mission on the information of patients, in collaboration "with all stakeholders: associations, patients, regulatory agencies, health professionals, journalists".
The results of the pharmacovigilance survey still awaited
Now the minister says she is waiting for the results of the pharmacovigilance survey conducted by the ANSM "to find out what were the serious cases reported". There are, according to the drug agency, 9000 cases reported to date, but "others will rise," says Agnès Buzyn.
"You have to analyze the side effects, whether you understand that they were serious or not serious." In these statements, many come from patients directly and what a patient feels as a serious side effect is not necessarily "serious" the medical meaning of the term, in terms of endangerment.It must be understood with the patients, because when a doctor speaks of serious side effect, it is a side effect that involves the lives of people ", says the minister.
Finally, Agnès Buzyn is in favor of a parliamentary commission of inquiry and to be "for the transparency" on this affair.
To report any adverse effects: www.signalement-sante.gouv.fr
* http://ansm.sante.fr/S-informer/Actualite/Diversification-of-the-specialites-of-the-base-of-thyroxine-Point-d-Information
