The Top Ten Stories Affecting Thyroid Patients in the Decade from 2000-2009

By Mary Shomon, About.com Guide

Updated March 24, 2010

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Throughout 2009, thyroid patients who take natural desiccated thyroid drugs have struggled. These drugs, known in the U.S. by the brand names Armour, Nature-throid, and Westhroid, and generically made by Major and Time Cap Labs, have been in back order, short supply, unavailable, and even gone off the market in some cases. The situation has left many patients and physicians scrambling for alternatives, and everyone confused as to what is actually going on behind the scenes.

What we do know:

• Armour Thyroid, made by Forest Labs, was reformulated in the spring, resulting in substantial problems for some users, who found it less effective, ineffective, or in some cases, found it to cause additional symptoms and problems
• After its reformulation, Armour became increasingly scarce, until it became completely unavailable in the late summer of 2009. As of the end of 2009, it remains unavailable except for sporadic releases of small quantities of 1 grain tablets of the reformulated pills.
• Forest categorically refuses to respond to consumer, media or professional requests for information about the reformulation, or the shortage of the "new" Armour.
• Nature-Throid (and its identical "sister" drug Westhroid), made by RLC Laboratories, also went into a backorder and shortage situation during the late summer of 2009.
• Both Forest and RLC cited a shortage of raw material -- desiccated thyroid powder -- as the reason for the shortages.
• The key supplier of desiccated thyroid powder in the U.S., American Laboratories, has not satisfactorily explained the shortage of raw material.
• During 2009, FDA actions resulted in the two generic manufacturers, TimeCaps Labs, and Major, stopping production of natural desiccated thyroid drugs
• The FDA confirmed that federal regulations view natural desiccated thyroid drugs as unapproved drugs (not grandfathered, and not viewed as "generally recognized as safe/effective" or GRAS/E). Natural desiccated thyroid drugs will, therefore, at some point be required to go through the new drug application (NDA) process.

Patients and practitioners, struggling to deal with the shortages and availability problems, turned to synthetic combinations and compounding, as well as importation of foreign drugs. At the same time, many banded together to form the Save Natural Thyroid Coalition, a grassroots movement to help legitimize natural desiccated thyroid and ensure its continued availability. Started in August of 2009, by year's end, the Save Natural Thyroid Coalition numbered more than 5,000 patients and practitioners, including a steering committee of the nation's top thyroid and hormonal medicine experts and advocates. Activities have been coordinated through the Save Natural Thyroid Facebook page and the Yahoo List.

A complete history of the 2009 natural desiccated thyroid shortage is online. As of the close of 2009, manufactured natural thyroid drugs are still not available in U.S. pharmacies, and the future of these drugs is in question.