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FDA Issues Warnings Over Unapproved Thyroid medications
The Food and drug Governance (FDA) has issued warnings to manufacturers and distributors of unapproved animal-derived thyroid medications, citing concerns over safety, effectiveness, and quality [[1]]. These medications, often sold under names like Armour Thyroid, NP Thyroid, and Natural Thyroid, are made from dried pig thyroid glands. While approximately 1.5 million Americans used these drugs in 2024 [[3]],they have not been approved by the FDA.
The FDA states that these medications may contain inconsistent hormone levels and carry a higher risk of contamination or impurities [[1]]. Unlike synthetic thyroid medications, which have undergone FDA review for decades, the animal-derived products have not been evaluated for safety or potency. In letters sent on August 6, the agency informed companies that it may take enforcement actions if they continue to distribute these unapproved drugs [[1]].
The FDA has also received reports of adverse events linked to these medications [[1]]. This action follows a history of scrutiny regarding desiccated thyroid extract (DTE) products, with questions raised as early as 2013 about whether they were “grandfathered” from the regular drug approval process [[1]].
Did You Know? Levothyroxine Sodium Tablets, a synthetic thyroid medication, have also been subject to recent recalls due to subpotency issues [[2]], highlighting the importance of medication quality control.
the FDAS concerns align with broader discussions about the regulation of compounded medications and the potential risks associated with unapproved drugs. Are you aware of the differences between synthetic and animal-derived thyroid medications, and the implications for your health? What steps can patients take to ensure they are receiving safe and effective thyroid treatment?
| Issue | Date | Action |
|---|---|---|
| Unapproved Thyroid Medications | August 6, 2025 | FDA issues warning letters to manufacturers and distributors. |
| DTE “Grandfathering” Question | 2013 | Concerns raised about regulatory status of desiccated thyroid extract. |
| Levothyroxine Recall | Recent | Recall issued due to subpotency. |
The FDA’s actions underscore the importance of adhering to established drug approval processes to ensure patient safety and efficacy. The agency’s commitment to addressing unapproved medications reflects a broader effort to maintain the integrity of the pharmaceutical supply chain [[3]].
Pro Tip: Always discuss your thyroid medication with your healthcare provider to ensure it is indeed appropriate for your individual needs and to address any concerns about its safety or effectiveness.
