FDA reviewing bone meds' fracture risk

In the wake of two new studies suggesting a link between bisphosphonates and a certain type of bone breakage, the FDA says it's in the midst of reviewing the drugs' safety. So far, the agency hasn't found "a clear connection" between the meds--including Merck's Fosamax; Sanofi-Aventis and Procter & Gamble's Actonel; and Roche and GlaxoSmithKline's Boniva--and the risk of subtrochanteric femur fractures.

The agency says it requested data from drugmakers in 2008 after reports of femur fractures in women using bisphosphonates. The update on this review comes after researchers presented two studies at the American Academy of Orthopaedic Surgeons' annual confab, one of which showed that prolonged therapy with the drugs may create bone that's more susceptible to fractures. The other showed that bone tissue among bisphosphonate patients was less heterogeneous than among women not using the drugs, which might affect bone quality.

Though the data it has reviewed hasn't turned up a clear link, the FDA says it's going to continue reviewing Fosamax and its ilk, seeking help from outside experts. In the meantime, it advises patients to stay on the meds, but to alert their doctors if they get new pain in the hip or thigh.

- see the FDA announcement
- read the Wall Street Journal story
- get more from Reuters

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