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Bisphosphonate Use Following FDA Safety Announcements

J Bone Min Res; ePub 2016 Mar 31; Kim, Kim, et al

Researchers evaluated the impact of 3 FDA drug safety announcements on the use of bisphosphonates in patients with hip fracture: osteonecrosis of the jaw (2005), atrial fibrillation (2007), and atypical femur fracture (2010). They found:

• Among 22,958 patients with hip fracture, bisphosphonate use decreased from 15% in 2004 to 3% in Q4 2013.

• Prior to the 2007 announcement, odds of bisphosphonate use increased 4% per quarter.

• After the 2007 announcement, there was a 4% decrease in bisphosphonate use per quarter.

• The 2007 announcement was associated with a significant decline in the rate of change in bisphosphonate use over time, but no impact on other osteoporosis medication use.

• After the 2010 announcement, odds of bisphosphonate use continued to decrease by 4% per quarter while the odds of other osteoporosis medication use remained stable over time.

• The 2007 announcement was significantly associated with a decrease in bisphosphonate use among patients with hip fracture.

Citation: Kim SC, Kim DH, Mogun H, et al. Impact of the U.S. Food and Drug Administration's safety-related announcements on the use of bisphosphonates after hip fracture. [Published online ahead of print March 31, 2016]. J Bone Min Res. doi:10.1002/jbmr.2832.