Levothyrox: extension of the old formula until the end of 2021

New twist. While Euthyrox – the old formula of Levothyrox – was no longer to be marketed in France in September 2020, patient associations learned this Friday of the extension of its marketing until the end of 2021. A victory for the many patients who continue to buy this drug which was first taken off the market in 2017.”Is it because all the associations demanded it or because in this time of Covid, the ministry wanted to avoid a new controversy? Either way, it’s a breath of fresh air,” comments Beate Bartès, president of the association ‘Vivre sans thyroid’ at the Parisian.

A reprieve requested by the Directorate General of Health (DGS) from the Merck laboratory, manufacturer of this drug. According to the administrative authority, this marketing extension is “essential” in view of the 75,000 patients who continue to consume the old formula of Levothyrox three years after the change of formula.

The Levothyrox Affair

Fifteen months of additional reprieve which does not change the substance of the case… for the moment, the Merck laboratory is responding favorably to the request of the French authorities, “in the interest of the patients”, and as long as that “is technically feasible”. The German manufacturer still intends to abandon the old formula for the new in all the countries where it markets Levothyrox. In February 2017, Merck modified the excipient – ​​secondary substance – of Levothyrox at the request of the National Medicines Safety Agency (ANSM). The French drug policy requires greater product stability over time. To do this, the manufacturer replaces the lactose, which coated the thyroid hormone – levothyroxine – to make a tablet, with mannitol. The ANSM and Merck are satisfied with the new version of Levothyrox which they consider more beneficial for patients. An opinion that some users do not share.

As early as spring 2017, some patients experience unwanted side effects. A deaf language ensued between the health authorities and certain patient associations, the former asking the latter to adopt the new formula while the others demanded the return of the old one. Of the 2.3 million patients treated in France, 17,000 cases of side effects have been identified. In total, 5,062 adverse effects had been classified as serious and 14 deaths were recorded by the ANSM, without a direct link with the new formula being able to be formally established.

Future in suspense

To calm the sling, the health authorities authorized the simultaneous marketing of Levothyrox as well as its old formula under the name of Euthyrox. A realizable market as long as Merck has not carried out the complete changeover of its production apparatus. After having received boxes intended for the German or Belgian market, French patients of Euthyrox are currently receiving drugs intended for the Russian market, recalls Le Parisien. The industrialist claims Parisian that “soon“The old formula will no longer be manufactured for any market.

The French health authorities enjoin the recalcitrant to switch to other formulas such as Levothyrox or the generics newly placed on the market. However, while some associations regret that some are not reimbursed by Social Security or that the price “waltzes” from one pharmacy to another, others are asking for the old formula to be maintained.