Drugs

FDA Signals Increased Scrutiny of Unapproved Animal-Derived Thyroid Drugs

FDA appears to be signaling that increased regulatory oversight might be on the horizon for unapproved animal-derived thyroid medications, which are used by an estimated 1.5 million Americans to treat hypothyroidism. The agency says it plans to issue new draft guidance outlining its enforcement priorities for such products.

An FDA post says it has notified manufacturers, importers and distributors of desiccated thyroid extract (DTE) products — including brands such as Armour Thyroid, NP Thyroid, Nature-Thyroid and Natural Thyroid — that it intends to publish guidance describing its compliance priorities as well as recommendations for developing products that could support future FDA marketing applications.

Although these animal-derived thyroid products have been marketed for years, they have never been approved by FDA. Unlike FDA-approved synthetic thyroid hormone therapies containing levothyroxine sodium or liothyronine sodium, the agency said DTE products have not undergone FDA review to establish their safety, effectiveness, purity or potency. FDA estimates that about 22 million patients received prescriptions for FDA-approved levothyroxine products through U.S. retail and mail-order pharmacies in 2024, compared with approximately 1.5 million prescriptions for unapproved animal-derived thyroid medications.

The FDA said it will continue applying a risk-based enforcement approach and may take action against manufacturers whose products fail to meet quality standards or otherwise place patients at risk. The agency also emphasized that animal-derived thyroid products are regulated as biological products under the Public Health Service Act and therefore are not eligible for pharmacy compounding.

The agency cited several safety concerns associated with unapproved DTE products. Because the medications are manufactured from dried animal thyroid glands, FDA said hormone concentrations may vary from batch to batch, potentially resulting in inconsistent dosing. Excess thyroid hormone can cause adverse effects, while insufficient hormone replacement may leave hypothyroidism inadequately treated. The agency also warned that the products may carry an increased risk of impurities related to their animal source or manufacturing process, raising concerns about infections and other health risks.

FDA said it has received patient complaints and adverse event reports involving the safety and potency of the unapproved products.

Additionally, FDA has advised patients currently taking animal-derived thyroid medications not to discontinue therapy on their own but to consult their healthcare provider or an endocrinologist about appropriate treatment options while manufacturers work toward obtaining FDA approval for these products.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

Read more

Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome