Why Forest Labs had gotten away with a “newly formulated” Armour that is causing so many problems
Numerous and ongoing comments to my blog posts below about the newly formulated Armour are shocking and despairing.
Additionally, thyroid patients are crying out about the loss of being able to do Armour sublingually. (Was Forest Labs not paying one hoot of attention to thyroid patients the last few years in their praise of Armour because of it’s sublingual effectiveness??) Sublingual administration was a godsend for thyroid patients who had digestive issues, including gluten intolerance and Celiac, as well as those who needed to take iron tablets (which you can’t do at the same time as you swallow desiccated thyroid, but could do with taking Armour subingually)
So how in the world did Forest Labs get away with reformulating and producing a product that so many patients are reporting to be problematic?
It’s not FDA approved. As many of you may know, Armour desiccated thyroid, even when it was produced by a pharmaceutical other than Forest Labs, was around far before the FDA (Federal Drug Administration) came into being in 1938. That’s why it does not have the designation of “FDA approved” as do those drugs which were created after the FDA existed. It’s called an unapproved drug, but Armour was presumed to be safe and effective already.
From the FDA: Under the 1938 grandfather clause (see 21 U.S.C. 321℗(1)), a drug product that was on the market prior to passage of the 1938 Act and which contained in its labeling the same representations concerning the conditions of use as it did prior to passage of that Act was not considered a new drug and therefore was exempt from the requirement of having an approved new drug application.
Because it’s not “FDA-approved”, it does not have an NDA, aka New Drug Application. An NDA is used by the FDA to establish if the pharmaceutical product is safe, EFFECTIVE, more beneficial than side effects, and has in-house “controls” which maintain the quality, strength and purity of the product. (Thanks to “Ben” the pharmacist for reminding me of this.)
So…without that NDA, Forest Labs is, and has been, on their own, including with the latest introduction of a newly formulated Armour. So you might say, WE as patients were the guinea pigs. And sadly, we’ve been squealing and it’s a muddy picture.
The most important fact to state: USP (United States Pharmacopeia) desiccated thyroid is an effective and important drug which is changing the lives of a huge and growing body of individuals around the world. That was evident before Armour was reformulated, and is still evident with products like Naturethroid or Westhroid, which many patients are switching to. See my blog post about Naturethroid here, plus RLC Labs comment about Naturethroid here.
But something has gone terribly wrong with the reformulation of Armour, and patients appear to be leaving it behind in the dust in favor of another great and effective brand like Naturethroid. And whether it’s the fillers are not, Forest needs to take a new look at their reformulation of what was once a GOOD product, and hopefully this time, LISTEN TO PATIENTS.
*Want to be informed of these important blog posts? Curious what’s on Janie’s mind? Just use the Notifications to the left and below the links.
*SALE! Stop the Thyroid Madness T-shirts are now 50% off just because I like sales. A great way to spread the word about our patient revolution for the superiority of desiccated thyroid over T4-only meds. You’ll also see funny bumper stickers. Also…when you order the STTM book and request it (i.e. you have to request it), you get a Calvin peeing on….(you’ll see) bumper sticker for FREE, and it’s a hoot.
