Bisphosphonate Update

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  • A FDA advisory committee wants FDA to limit the duration of bisphosphonate therapy for treatment of osteoporosis, but the committee could not agree on what that time limit should be.
  • FDA wants bisphosphonates use warning on the label that optimal duration of use hasn’t been determined, and that all patients on bisphosphonate therapy should have their need for continued therapy re-evaluated periodically.
  • The issue has become a hot potato for the FDA as reports have emerged linking long-time bisphosphonate therapy with increased risk of atypical fractures.
  • Placebo-controlled trials typically provide data for only five years of therapy, but there is no strong clinical evidence that bisphosphonates work better after they’re used for a long period of time, nor is there firm evidence that long-term use causes harm.
  • Bisphosphonates have been shown to reduce the risk of breaking a hip by 40% to 50% and fracturing a vertebra by between 40% and 70% by inhibiting bone resorption to prevent loss of bone mass.
  • In 2010, the FDA required makers of bisphosphonate drugs to add a warning to their labels about a small increased risk of atypical femur fractures after an American Society for Bone and Mineral Research task force concluded that the risk, although it is small, is real.
  • The panel was also concerned with the drug’s link to deterioration of the jawbone. In 2005, the FDA added a warning on bisphosphonates about osteonecrosis of the jaw, a rare disease in which the bone in the jaw dies.
  • There are also some data suggesting a link to long-term use of bisphosphonates and esophageal cancer. A study in the New England Journal of Medicine used data from FDA’s Adverse Event Reporting System to identify and describe 23 patients taking alendronate who were diagnosed with esophageal cancer.
  • There’s no doubt that these are very efficacious drugs that reduce fractures and mortality. But the issue is that should this drug be used for more than three years.
  • Some suggest taking a “drug holiday” or taking a break for bisphosphonate treatment in order to minimize risks.