Old Levothyrox formula available in France until end of 2021
The previous formula of controversial hypothyroid medication Levothyrox is to be available in France until the end of 2021, health authority la Direction Générale de la Santé (DGS) has confirmed.
The drug, now named Euthyrox and made by pharmaceutical giant Merck, was due to be phased out by the end of September this year - to be completely replaced with the controversial “new formula” - but Euthyrox will now be available to patients until the end of next year.
Making the old formula of the drug available to patients who request it has long been campaigned for by patient associations, who have claimed that the new version of the drug does not work in the same way as the previous one, and in many cases leads to symptoms and conditions returning.
Merck has always denied this claim, and said that the new formula is “bioequivalent” to the old one, and that the active ingredients have not changed.
The new version of the drug has been sold by Merck since 2017, but it has been beset with alleged problems since its release.
Now, a letter signed by the director general of health, Jérôme Salomon, confirmed to patient association Vivre Sans Thyroïde (Living Without A Thyroid) that “in the context of the global health crisis linked to the Covid-19 epidemic and its consequences on the organisation of healthcare...the ANSM asked the Merck laboratories to do everything possible to maintain Euthyrox in France beyond September 2020”.
The ANSM is the healthcare and drug safety agency, l’Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM).
Beate Bartès, head of patient organisation Vivre Sans Thyroïde, told newspaper Le Figaro that she was “surprised” and “satisfied” with the news.
She said: “Since Autumn 2017, we have had committee meetings with patients, the DGS, the ANSM, the [doctors council] l’Ordre des Médecins...During a meeting in January, they announced to us that the old formula would no longer be distributed after September.
“Then, during the 6 July committee, we worked with two other associations to highlight the risk of this stoppage right in the middle of a pandemic period. Two days later, the DGS said that the date would remain. We then wrote to the ministry of health on July 16.”
During a telephone meeting on August 7, the extension of the drug was confirmed.
The DGS said that Merck had finally “responded positively” to their request, to give people “extra time to alter their treatment as soon as possible, to find a long-lasting alternative”.
According to the DGS, there are 75,000 patients still using the old formula of the drug in France.
Ms Bartès said: “We are very happy for this respite and we will continue the fight for a more definitive solution because this will not resolve all of the problems. Our associations have been receiving messages from patients worrying about the change in treatment for months.
“We want people who have always taken the old formula without any issues, to be able to continue taking it.”
Years of controversy
Hypothyroidism is a condition that can cause extreme fatigue, depression, weight gain, hair thinning and “brain fog”, among other debilitating symptoms. Some patients also take the drug if they have had thyroid cancer, or had their thyroid removed.
There are currently five thyroid medications in France, although Levothyrox has traditionally been the most common. The new formula was introduced in France in spring 2017.
Weeks later, patients across the country began to complain of side-effects returning and the new drug not working as well as the old one.
Pending further investigations, then-health minister Agnès Buzyn ordered 130,000 boxes of the old formula nationwide, half of which sold out within two days, and a helpline number was set up for patients.
Patient advocate groups later launched multiple court cases against the manufacturer.
Merck has always maintained that its new formula is “bioequivalent (medically identical)” to the old one, and that only non-active ingredients of the drug were changed, to conform to new medication rules from medical safety agency l'Agence Nationale de Sécurité du Médicament (ANSM).
In July 2018, the ANSM confirmed that the drug was “good quality” and effective, but patient associations have continued to dispute this. In April 2019, a new and independent France-UK study found that the new formula was “not equivalent” and could work differently in some patients.
In September 2018, French senator Laurence Cohen called for a new inquiry to “get a real view of the situation”.
In March 2019, a court case against Merck - which attracted so many people, including aggrieved patients, that it was forced to open in a concert hall in Lyon rather than a law court - was initially dismissed due to a “lack of information” from the plaintiffs.
In February 2019, the allegations against Merck even included manslaughter, after a woman died due to alleged links to the lack of effectiveness of the new drug formula.
In June this year, the Court of Appeal in Lyon ordered Merck to pay €1,000 to more than 3,000 plaintiffs, and recognised that Merck had committed “an error” when changing its treatment.
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