Pfizer's Fablyn is taken once daily as a tablet to prevent fractures in postmenopausal women with osteoporosis. The drug lasofoxifene tartrate or Fablyn was rejected by the FDA in September 2005 as a medicine to prevent osteoporosis.
The world's largest drug maker is seeking approval from FDA to market the drug and decided last year to resubmit the drug after re-examining safety data. Fablyn belongs to a class of drugs known as selective estrogen receptor modulators, or SERMs, which includes Eli Lilly and Co's osteoporosis drug Evista.
Pfizer's drug showed positive results for preventing fractures in a study of over 8,500 postmenopausal women between ages 60 and 80. The percentage of patients who developed new fractures while taking Pfizer's drug was 3.8 percent, compared with 6.4 percent of those taking placebo.
In its review of the drug posted online, the FDA expressed concerns about higher rates of death and blood clots among women taking a lower dose of the drug, which regulates the feminine hormone estrogen. At the lower dose of 0.25 milligrams there was a rise in combined fatalities from all forms of cancer.
The agency will ask a panel of outside advisers that meets on Monday if Fablyn offers acceptable safety, the staff summary said. An advisory committee will meet Sept. 8 in Rockville, Maryland, to recommend whether the product should be approved.
