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September 9, 2019

Improving Adverse Event Reporting for Compounded Drugs

Author Affiliations
  • 1Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland
JAMA Intern Med. Published online September 9, 2019. doi:10.1001/jamainternmed.2019.3830

During a routine inspection unrelated to compounded drugs, US Food and Drug Administration (FDA) investigators found records of 4202 adverse events, none of which had ever been reported to the agency.1 The reports, kept in a company-generated data file, concerned the possible association of compounded hormone pellets marketed by BioTE Medical (BioTE) with cancers (including endometrial and prostate cancers), strokes, heart attacks, deep vein thrombosis, cellulitis, and pellet extrusions, as well as adverse events known to be caused by supratherapeutic hormone concentrations.

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