USA – FDA Investigates Thousands of Adverse Events Linked to Compounded Hormone Drugs

The US Food and Drug Administration (FDA) said Monday that an inspection of an outsourcing facility uncovered information about 4,202 adverse events linked to compounded hormone pellets that had never been reported to the agency.

Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, said in a statement that the mishap highlights the need for compounders of drugs and other affiliated organizations to report adverse events promptly.

“The adverse event information our investigators found suggested compounded hormone pellets were possibly associated with endometrial cancer, prostate cancer, strokes, heart attacks, deep vein thrombosis, cellulitis and pellet extrusion,” she wrote. “However, because the reports lacked certain critical information, the FDA was able to attribute only a small percentage of the adverse events (61 reports), such as pellet extrusion and cellulitis, to the use of compounded hormone pellets containing testosterone.”…