New FDA Analysis Cautions against the Long Term use of Fosamax in Light of its Limited Benefits and the Possibility of Complications.
On May 9, 2012, a new U.S. Food and Drug Administration (“FDA”) analysis cautioned against long term use of Fosamax due to its uncertain benefits and the possibility of bisphosphonate complications. The FDA analysis, published in The New England Journal of Medicine, was motivated by a growing debate over how long women should continue using the drugs, known as bisphosphonates, which are sold as generic versions of brands like Fosamax and Boniva. The FDA’s analysis reviewed the long term use of bisphosphonates and found that the drugs offered little, if any, benefit after three to five years of use. According to the FDA, “the long-term safety and efficacy of bisphosphonate therapy for osteoporosis are important concerns for the FDA. In response to post marketing reports of rare but serious adverse events associated with bisphosphonates, such as atypical femur fractures, osteonecrosis of the jaw, and esophageal cancer, the FDA performed a systematic review of long-term bisphosphonate efficacy.”
As reported by the New York Times, the concern is that after years of use, the drugs may in rare cases actually lead to weaker bones in certain women, contributing to “rare but serious adverse events,” including unusual femur fractures, esophageal cancer and osteonecrosis of the jaw, a painful and disfiguring crumbling of the jaw bone.
According to the New York Times, some women with moderate bone density and no other risk factors are unlikely to derive benefits from long term use of bisphosphonates. Yet, women continue to take these medications for years. Dr. Clifford J. Rosen, an endocrinologist and researcher at the Maine Medical Center Research Institute told the New York Times, “I think a lot of people are going to come off this drug.” In an accompanying article in The New England Journal of Medicine by Dr. Rosen and others, the researchers estimate that perhaps 60 percent to 70 percent of current users would be candidates for coming off the drugs after three to five years.
According to the study, women who have been diagnosed with osteopenia, a mild version of low bone density, are especially good candidates to stop taking bisphosphonates after three to five years, particularly in light of the recent safety concerns.
Attorneys at Pope, McGlamry are filing lawsuits against the drug manufacturers on behalf of individuals who have experienced bisphosphonate complications such as atypical femur fractures. If you or a loved one has suffered a femur or thigh-bone fracture after taking Fosamax, Actonel, or Boniva, contact our Georgia pharmaceutical litigation attorneys today. Schedule a free consultation.