Pfizer's bone drug may cause deaths, FDA analysis reports

[WillYourVoteBCounted]

Women who got low doses of Pfizer's Fablyn -- a drug candidate for osteoporosis -- were more likely to die within five years compared with those who received placebo, according to an analysis from FDA staff. Reviewers said the once-daily pill is effective for averting fractures in postmenopausal women with osteoporosis, but they are concerned that patients on Fablyn had more than twice the risk of developing blood clots. A panel of independent advisers is scheduled Monday to review the drug's safety

Pfizer's bone drug may cause deaths, FDA analysis reports
The Washington Post/Reuters (9/4)

WASHINGTON (Reuters) - Osteoporosis patients who received a low dose of an experimental Pfizer Inc (PFE.N) 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 given the highest dose of the Fablyn drug was not statistically significant in the company study and therefore could have been due to chance, Food and Drug Administration reviewers said.

The drug, which the FDA rejected for osteoporosis in 2005, was developed with technology from Ligand Pharmaceuticals Inc (LGND.O).

The FDA staff also said it was "of concern" that Fablyn patients had more than double the chance of developing a blood clot in a vein. Blood clots are a known risk of similar drugs.

...more at the link
http://www.washingtonpost.com/wp-dyn/content/article/2008/09/04/AR2008090401814.html

[SheilaT]

1. How interesting.

I have a friend who's a physician, and is uncritical accepting of every new drug that comes down the pike. She was recently hospitalized with a serious blood clot. I wonder if she was taking this drug. Maybe I'll ask.