FDA Panel Says Risks Of High-Grade Tumors With Merck Drug Outweigh Benefits
FDA Panel Says Risks Of High-Grade Tumours With Merck Drug Outweigh Benefits
From Canadian Press DataFile (December 1, 2010)
WASHINGTON – A panel of U.S. federal health experts unanimously rejected the use of Merck’s Proscar to prevent prostate cancer, saying the drug could actually raise the risk of the most serious types of tumours.
The Food and Drug Administration panel of cancer experts voted 17-0 with one abstention that the drug’s risks outweighed its benefits. The panel is scheduled to vote later on a similar drug from GlaxoSmithKline.
Studies by both companies showed their drugs decrease low-grade prostate tumours by nearly 25 per cent.
However, panellists noted that a small number of men treated with the drugs actually developed more aggressive tumours. Panellists said the risk of increasing deadly tumours outweighed the reduction in tumours that are seldom fatal.
The FDA is not required to follow the panel’s advice, but often does.
Posted: December 2010