Expert Panel Links Popular Bone Drugs to Rare Fracture

FDA should add warning label to meds such as Boniva, Fosamax, panelists say

There is conflicting evidence that bone strengthening drugs (biophosphonates) trigger a weakness which makes a particular thigh bone fracture likely in rare cases. However, an expert panel believes there is enough for a special warning on labels for biophosphonate containing drugs as Actonel, Boniva and Fosamax.

The panel is recommending that the FDA :

Change the product’s labeling to alert doctors and patients to the risk of these fractures and their warning signs.

Develop new diagnostic codes for these fractures that will improve reporting of these cases.

Establish an international registry of patients with these fractures to track cases and provide data for research.