Bisphosphonates under scrutiny in Europe over link to stress fractures

28 September 2010

A review of the safety of bisphosphonate drugs used to treat osteoporosis and other bone disorders has got underway in Europe, in light of reports linking them to stress fractures of the femur.

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) announced the review of widely-prescribed drugs such as Merck & Co's Fosamax (alendronate) and Sanofi-Aventis' Actonel (risedronate) late last week.

Fosamax's labelling was updated in 2008 to include a warning about atypical stress fractures of the proximal femoral shaft, but the CHMP now wants to take a comprehensive look at all the available data on bisphosphonates and stress fractures to see whether this is a class effect.

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