FDA Flags Gaps in Adverse Event Reporting for Compounded Hormone Pellets

The FDA has issued a statement describing a gap in safety reporting for compounded hormone pellet products, according to the agency's press announcement. During a 2018 inspection of BioTE Medical, investigators found 4,202 adverse events that had never been reported to the agency, collected over five years but never forwarded.

Because many reports lacked key details, the FDA could only directly attribute 61 cases, mostly pellet extrusion and cellulitis, to compounded testosterone pellets, though the broader dataset raised concerns involving endometrial cancer, prostate cancer, stroke, heart attack, and deep vein thrombosis. The agency notes compounded bioidentical hormone products are not FDA approved and carry no guarantee of safety or effectiveness, unlike reviewed hormone therapies.

The statement names three companies involved, Carie Boyd's Prescription Shop, AnazaoHealth Corporation, and BioTE Medical, and notes BioTE was not registered as an outsourcing facility despite collecting its own adverse event data through a customer portal. The FDA says it is continuing to investigate and reminds outsourcing facilities that they are legally required to report adverse events and label products accordingly.

For readers following compounded and investigational products generally, this underscores why safety signals depend on consistent reporting, something regulators and manufacturers both have to get right.

This article is for education only. It is not medical advice. Compounds discussed here are sold for research purposes. Talk to a licensed clinician before making health decisions.