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SEPTEMBER 10, 2019

FDA: Outsourcer Hid Adverse Reactions Related to Compounded Hormone Pellets

By Nikki Kean
Investigators from the FDA have discovered records of 4,202 adverse events related to compounded products, none of which had ever been reported to the agency, according to a new report published in JAMA Internal Medicine (2019 Sep 9. [Published online]).

The reports, kept in a company-generated data file, concerned the possible association of compounded hormone pellets marketed by BioTE Medical (BioTE) with the development of cancer, stroke, heart attack, deep vein thrombosis