To whom can Levothyrox patients with side effects still turn to know the end of story about the new Levothyrox® formula?
Received by Agnès Buzyn, Minister of Health and National Solidarity last week, the associations Live Without Thyroid (VST) and the French Association of Thyroid Patients (AFMT), anxious to shed light on this case side effects attributed to the new drug formula Merck laboratory, were able to get some answers to their questions.
But everything is not settled yet.
The use of a generic of the old formula Levothyrox evoked
"Merck will not return to the old formula, but the minister has promised us that there is a similar to that of Merck generic version and with lactose.This famous formula is produced by a Dutch laboratory belonging to the pharmaceutical group Mylan This is the copy-paste of the old formulation assured us the minister, "says Chantale L'Hoir, president of the AFMT
The association has therefore asked for its immediate release. Response from the Minister of Health: "She tells us that there is a minimum waiting time of 4 weeks for health products sold in northern Europe to obtain the French AMM and ISO standards," says President of the association It is not possible, there is a health emergency, this situation must be resolved within 15 days. "
Drops of L-Thyroxine SERB: a drug alternative considered
For the French Association of Thyroid Patients, it is essential not to limit to children and elderly people with swallowing problems only taking drops of L-Thyroxine (the liquid version of the Levothyrox old formula produced by the laboratory SERB), but to extend it to vulnerable people.
Problem: Health authorities fear a shortage. However, according to Figaro * information, the manufacturer would have the capacity to double its production.
For its part, the association Living Without Thyroid requires, via a letter to Agnès Buzyn and Dominique Martin, President of the National Agency for Safety of Health Products and Medicines (ANSM) published on its website on September 12 ** lastly, that "clear information on the capacity of production and increase of the quantities of the SERB laboratory, of the stock to be placed on the market as well as the deadlines" is given.
But also that a briefing note "with a clear prescribing order" of the drug is produced "as soon as possible" for the doctors.
Pharmacovigilance data from the old Levothyrox formula required by associations
In order to be informed "of the extent of the reports before the change of formula", VST says it wants to consult the pharmacovigilance data of the old formula of Levothyrox. It also requires that "the complete dossier of bioequivalence, including the stability studies which led to the placing on the market of the new formula, be communicated to him".
Similarly, she claims that this file popularized and made public "to address the anxiety of patients."
The lack of information of health professionals and patients pointed the finger
The Minister of Health herself acknowledged that there was a lack of information on the new Levothyrox formula.
Thus, Living Without Thyroid provides "guidelines" *** to accompany patients on the procedure to follow in case of side effects. At the same time, she calls for clear instructions, which "should take into account the symptoms and concerns of patients", to be given to health professionals.
A way to unravel the truth from the fake and avoid "circulation of rumors and false news" she says. Social networks are often the first channels of misinformation on these topics.
For its part, the AFMT believes that the ANSM is entirely responsible for this flaw and calls for the resignation of its president, Dominique Martin. "It was not up to par, when you have a responsibility of this level, you can not afford to do anything," protests Chantal L'Hoir.
Urgency: preventing the cessation of treatment and drug trafficking
Because what certainly worries the associations, it is the multiplication of the testimonies of patients ready to stop their treatment, inciting-voluntarily or non-others to do the same.
"Currently we are in the situation where people feel better by stopping their treatment for a few days and it's sad to say but do not, alert Chantale L'Hoir." You have a stomach ache, badly everywhere, The heart is a pump that circulates the blood, and it is started by the thyroid hormones that manage its heartbeat.If we end up in hypothyroidism, we risk to accumulate waste in the blood and stroke, that's very serious. "
According to her, the risk of "letting this situation rot" also poses the problem of drug trafficking. In fact, many patients who are helpless in the situation are ready to seek solutions abroad or on the Internet and to offer them to others, without really knowing what they are buying and consuming.
An information meeting and a white march to come
Motivated by the same cause, defend the interests of people with thyroid disorders, the two associations want to set up events to continue to support and inform them.
Thus, the association Living Without Thyroid organizes an information meeting **** at the Conception Hospital (AP-HM) of Marseille on September 13, 2017 in the presence of professors Frédéric Sebag, Frédéric Castinetti and David Taieb.
The French Association of Thyroid Patients wants to organize soon "a white march of all health scandals".
The goal ? Continue to fight and encourage citizens to exercise their right to health. For Chantale L'Hoir, it is certain: it is "a social achievement that we must continue to protect". And to add "people must understand that we can make things change, it is a movement to fight against the health injustices that we suffer.
http://sante.lefigaro.fr/article/levothyrox-des-gouttes-comme-possible-substitution/
** www.forum-thyroide.net/index.html?https://www.forum-thyroide.net/phpBB/viewtopic.php?p=461191#461191
** www.forum-thyroide.net/index.html?https://www.forum-thyroide.net/phpBB/ftopic53906.html
*** http://www.ap-hm.fr/agenda/reunion-d-information-levothyrox-13092017
