Six months after the FDA determined there is no link between bisphosphonates and thigh-bone fractures, a task force says otherwise. Convened by the American Society of Bone and Mineral Research, the 26-person panel reviewed 310 cases of atypical femur fractures and found that 94 percent, or 291 patients, had taken the drugs, most for more than five years. This is the same task force report the FDA has been waiting to see before issuing recommendations (back story).
The panel also found that more than a quarter of patients who experienced atypical femur fractures in one leg experienced a fracture in the other leg as well. On the other hand, the panel pointed out that atypical femur fractures represent less than one percent of hip and thigh fractures overall and therefore are very uncommon. And so the task force suggests additional product labeling, better identification and tracking of patients experiencing the breaks, and more research to determine whether and how the drugs cause serious, but uncommon fractures.
"For the vast majority of patients with osteoporosis, these drugs are an important weapon against fractures and their benefits far outweigh the risks of using them," Columbia University's Elizabeth Shane, who headed the panel, says in a statement. "However, we are concerned that there may be a relationship between these fractures and long-term bisphosphonate use and, although the risk is low, we want to make sure that people know about the warning signs."
Which drugs are we talking about? Merck sells Fosamax, a $1.1 billion seller; Roche markets Boniva, another $1 billion med; Novartis sells Reclast and Warner Chilcott has Actonel. Earlier this year, two studies found that bones of some post-menopausal women who take the meds on a long-term basis to prevent osteoporosis can stop rejuvenating and become brittle.