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FDA Safety Announcement Affected Bisphosphonate Use

Four percent decrease in odds of bisphosphonate use each quarter after safety announcement for a-fib risk

WEDNESDAY, March 16, 2016 (HealthDay News) — A U.S. Food and Drug Administration safety announcement relating to atrial fibrillation risk associated with bisphosphonates correlated with a reduction in bisphosphonate use, according to a study published online March 11 in the Journal of Bone and Mineral Research.

Seoyoung C. Kim, M.D., Sc.D., from Brigham and Women’s Hospital in Boston, and colleagues used claims data from a U.S. commercial health plan to examine the impact of three FDA drug safety announcements on the use of bisphosphonates (in 2005 relating to osteonecrosis of the jaw; in 2007 relating to atrial fibrillation; and in 2010 relating to atypical femur fracture). Data were obtained for 22,598 patients with hip fracture from 2004 to 2013.

The researchers found that bisphosphonate use decreased from 15 percent in 2004 to 3 percent in the last quarter of 2013. There was a 4 percent increase in the odds of bisphosphonate use every quarter prior to the 2007 announcement; a 4 percent decrease in the odds of bisphosphonate use was seen after the announcement. The 2007 announcement correlated with a significant decline in the rate of change of bisphosphonate use (P < 0.001). The odds of bisphosphonate use continued to decrease by 4 percent per quarter after the 2010 announcement.

“The FDA safety announcement related to atrial fibrillation in 2007 was significantly associated with a decrease in bisphosphonate use among patients with hip fracture,” the authors write.

Two authors disclosed financial ties to the pharmaceutical industry.

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