Monday, September 9, 2019

September 9, 2019 Improving Adverse Event Reporting for Compounded Drugs Julie Dohm, JD, PhD1; Jenny Kim, PharmD, BCPS1; Janet Woodcock, MD1


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.

No comments: