Long-term exposure to a class of osteoporosis drugs called bisphosphonates is associated with serious side effects, including osteonecrosis of the jaw (ONJ), atypical subtrochanteric and femoral diaphyseal fractures, and esophageal cancer, according to a report from the U.S. Food and Drug Administration (FDA).
Additionally, data suggests that long-term (i.e. 3 to 5 years) exposure to the drugs, which includes Merck’s Fosamax and Roche’s Boniva, brings little or no incremental benefit in combating osteoporosis, the FDA added.
As a result, an FDA panel is recommending that makers of bisphosphonates be required to clarify how many years patients should take their drugs. Current labels state: “optimal duration of use has not been determined.”
Because the FDA’s report on bisphosphonates emphasizes that the data only shows an association with, but not causing, serious side effects, the agency is urging researchers to conduct more studies, including ones that control for other factors that could cause the side effects.
