Real world clinical experience with a new formulation of levothyroxine engineered to meet new and stricter regulatory requirements

[helvella]

I'm sure many who were around remember the major rumpus in France when Merck introduced new formulation Euthyrox - patients demonstrating and the old formula at least temporarily re-introduced.

The big change was to use mannitol rather than lactose. (Which seems to be the big difference between Teva and the other UK makes of levothyroxine.)

There is now a paper discussing the Euthyrox issues.

I'll not make any further comment before you read the article - please comment as you wish.

Bizarrely, if I have understood correctly, you can get the paper read out to you!

Endocrinology

Real world clinical experience with a new formulation of levothyroxine engineered to meet new and stricter regulatory requirements

Ulrike Hostalek-Gottwald

&

Yorki Tayrouz

Received 18 Aug 2021, Accepted 07 Sep 2021, Accepted author version posted online: 09 Sep 2021

• doi.org/10.1080/03007995.20...

Abstract

Objectives

A new LT4 formulation (Euthyrox®, Merck Healthcare KGaA, Darmstadt, Germany [LT4 NF]) was developed to meet new regulatory standards, and has replaced the older formulation (LT4 OF) in a number of countries. We evaluated the possibility of tolerability/safety concerns associated with the switch by analysing spontaneous adverse event (AE) reports before and after switching.

Transparency statement

Declaration of funding

This study was funded by Merck Healthcare KGaA, Darmstadt, Germany. A medical writer (Dr Mike Gwilt, GT Communications) provided editorial assistance, funded by Merck Healthcare KGaA, Darmstadt, Germany.

Declaration of financial/other relationships

UH and YT are employees of Merck Healthcare KGaA, the pharmaceutical sponsor of the LT4 products described here.

Author contributions

UH and YT conceived, designed and performed the study, and interpreted its results. Both authors were involved closely in developing and finalising the manuscript, and approved the final version for submission.

tandfonline.com/doi/full/10...

[LindaC]

But surely the 'reading out' is for the benefit of endos!? 😅😂

Alas, I couldn't take it 'straight', Levo! ☘️ Thank you!

[jgelliss]

Helvella Thank You for this post. I'm just wondering or maybe I really shouldn't . Who exactly is really benefiting ? I can probably take a guess that it's not us the *Thyroid Patients* . So now they reformulated the NDT's and that turned out to be a failure for most part . Now they are going to reformulate the T4 that is good for most part and make it worse? What's the deal ??? It makes one head spin in disbelief . Personally why can't they omit some of the fillers that we as thyroid patients can do very well without ? Why don't they put all the money that we Thyroid Patients sponsor for our thyroid meds and put to *Good Use* and make T4 with less fillers that work *Optimally* for all of us and I mean even those of us with sensitivities dye free ?

[jgelliss in reply to jgelliss]

In truth prior to any reformulations /improvements they make to any of our thyroid meds. They ought to consult with *Thyroid Meds Users* .

[Jazzw]

Loving their definitions of “non-serious” side effects. We all enjoy having crushing fatigue, don’t we?

[Esmielola]

It is very easy to see that this company are moving into the ‘lactose free market’. This will boost sales. Who cares how people ‘feel’ especially when they’re mostly women. All in the name of improvement. Or am I missing something here? Will there be any mannitol free products once the ‘new standards’ are adhered to?