Millions of people suffer from hypothyroidism, a condition in which the thyroid gland does not produce enough thyroid hormones to meet the body's needs. To treat this condition, doctors have traditionally relied on desiccated thyroid extract (DTE) drugs, such as Armour Thyroid, Nature-Throid, NP Thyroid and WP Thyroid. These drugs have been around for decades and remain popular among holistic, alternative and integrative physicians. However, they are not approved by the U.
S. Food and Drug Administration (FDA).The FDA has been encouraging manufacturers of unapproved drugs to seek FDA approval, as required by law. This approval process helps ensure that drugs are safe and effective for their intended use. Without it, patients are exposed to potential risks due to the lack of safety, efficacy and quality reviews.
The American Thyroid Association (ATA), a professional group of endocrinologists and researchers, has taken a position in favor of synthetic thyroid (Synthroid or levothyroxine) over DTEs. This is likely due to the fact that pharmaceutical companies that produce levothyroxine have become the main sources of funding for thyroid and endocrinology associations, educational programs in medical schools regarding thyroid disease, research grants for groups and individuals studying levothyroxine, and have distributed many millions of dollars in free samples, lunches and gifts printed with the logo to promote the drug. Armour Thyroid already has about twice the price of its competitors, including its FDA-designed generic equivalent, NP Thyroid. Despite this high cost, many people continue to use unapproved products made of animal origin. I predict that Armour Thyroid will quickly navigate through the FDA process and gain formal approval as a “biological thyroid hormone replacement drug”.Before synthetic thyroid (Synthroid or levothyroxine) existed, doctors relied on DTE to treat people with underactive or missing thyroid glands.
Over-the-counter glandular thyroid support supplements are not the same as prescription DTEs, nor are they a substitute for prescription thyroid hormone replacement drugs. The FDA's drug approval process is essential for ensuring that drugs are safe and effective for their intended use. It is unclear why Armour Thyroid has not yet been approved by the FDA but it is likely due to the fact that pharmaceutical companies that produce levothyroxine have become the main sources of funding for thyroid and endocrinology associations. Nevertheless, I predict that Armour Thyroid will soon gain formal approval as a “biological thyroid hormone replacement drug”.