Sep 4, 2008
FDA staff note deaths in Pfizer bone drug study
By Lisa Richwine
WASHINGTON (Reuters) - Osteoporosis patients given a low dose of an experimental Pfizer Inc pill were more likely to die within five years than others who got a placebo, U.S. drug reviewers said in an analysis released on Thursday.
An increased death rate for women who took the highest dose of the drug Fablyn was not statistically significant in the company study, Food and Drug Administration reviewers said. That means the difference could have been due to chance.
The drug, which the FDA rejected for osteoporosis in 2005, was developed with technology from Ligand Pharmaceuticals Inc.
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