Long-Term Bisphosphonate Use Linked To Subtrochanteric And Femoral Shaft Fractures, Also Called Femur Fractures
(Posted by Tom Lamb at DrugInjuryWatch.com)
An article published in the February 23, 2011 edition of the medical journal JAMA (Journal of the American Medical Association) reports on research finding that older women who used Fosamax, Boniva, Reclast, or other bisphosphonate drugs had a significant increased risk of suffering leg fractures involving their thigh bone, or femur.
From the beginning of this February 2011 JAMA article, "Bisphosphonate Use and the Risk of Subtrochanteric or Femoral Shaft Fractures in Older Women":
An increasing number of case reports describe women who develop fractures involving the subtrochanteric or shaft region of the femur in the setting of long-term bisphosphonate therapy, generally after minimal trauma. Fractures at these sites are often described as atypical because of their location and characteristic radiographic appearance. The US Food and Drug Administration recently announced its intent to actively monitor instances of bisphosphonate-induced atypical fracture, and the American Society for Bone and Mineral Research9 has released a task force report regarding the case definition, epidemiology, and need for additional research on these fractures.
Case reports and conflicting findings from small observational studies have left clinicians and patients uncertain about whether bisphosphonates increase the risk of subtrochanteric or femoral shaft fractures. We explored the association between long-term bisphosphonate use and subtrochanteric or femoral shaft fractures in a large population of postmenopausal women. [footnotes omitted]
The botton line: These researchers found that women ages 68 and older who took bisphosphonates like Fosamax, Boniva, or Reclast for five years or more were 2.7 times more likely to be hospitalized for fractures of the thigh bone compared with women who used bisphosphonates for fewer than 100 days.
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A February 22, 2011 Bloomberg news report, "Bone Drugs by Merck, Roche, Novartis May Add Leg Fractures", put the researchers findings into context:
Merck’s Fosamax was the first bisphosphonate marketed to treat and prevent osteoporosis in older women. The drug reached sales of $3.19 billion in 2005 before facing competition from cheaper generic copies. The drug had sales of $926 million last year, according to data compiled by Bloomberg....
Roche’s Boniva had 2010 revenue of $975 million, and Novartis’s Reclast and Aclasta had sales of $579 million....
Three previous studies were unable to prove a link between bisphosphonates and the atypical fractures.
Over the past three years we have written several articles about the association between Fosamax and femur fractures:
Our law firm is currently handling numerous femur fracture Fosamax lawsuits that have been filed against Merck, and is continually investigating more potential Fosamax cases.
We offer a no-charge, no-obligation, and strictly confidential Fosamax case evaluation for people who suffered a leg bone fracture in the thigh or hip area while using Fosamax or after stopping Fosamax.
P.S. "Bisphosphonates Class Label Change" regarding femoral fractures: Safety Information @ FDA.gov
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