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Regulatory Focus™ > News Articles > 2019 > 9 > FDA Investigates Thousands of Adverse Events Linked to Compounded Hormone Drugs

FDA Investigates Thousands of Adverse Events Linked to Compounded Hormone Drugs

Posted 09 September 2019 | By Zachary Brennan 

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.”

Part of the reason why FDA did not receive the adverse event reports is that the marketer of the hormone pellets, BioTE Medical, is not registered with FDA as a drug manufacturer, whereas the actual manufacturers of the compounded products, Carie Boyd’s Prescription Shop and AnazaoHealth Corporation, did not receive the adverse event reports.

Moving forward, Woodcock said FDA will do more to ensure that adverse events are collected and sent to FDA by compounders, outsourcing facilities and other related entities.

“In view of the lower regulatory standard for compounded products and increased risk that such unapproved products present, the FDA plans to take concerted steps to improve adverse event reporting and analyses,” she wrote in a JAMA Viewpoint on Monday. “As part of this initiative, the FDA has contracted with the National Academy of Sciences, Engineering, and Medicine to conduct a study on the risks associated with compounded hormones. This study, expected in 2020, will inform the FDA’s regulatory decision-making, including its review of labeling and marketing materials.”

JAMA Viewpoint


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