An FDA review published in The New England Journal of Medicine online led to concerns over how long women should continue using the drugs, known as bisphosphonates, which are sold as generic versions of brands like Fosamax and Boniva, as well as Novartis’s Reclast.
The concern is “rare but serious adverse events,” after prolonged use. This includes unusual femur fractures, esophageal cancer and osteonecrosis of the jaw, a painful and disfiguring crumbling of the jaw bone.
The FDA’s analysis found little, if any, benefit from the drugs after three to five years of use.
The FDA report offered little specific guidance about long-term use. It said that the decision to continue or stop treatment should be based on an individual assessment of risks, benefits and preferences discussed between a patient and her doctor. The agency did say that women at low risk for fracture or with a bone density near normal may be good candidates to stop therapy after three to five years, but older patients at higher fracture risk and bone density “in the osteoporotic range” may benefit from continued therapy.[related_posts limit=”5″]