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.
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.