EU Agency Starts Safety Probe of Common Bone Drugs - Looking at Bisphosphonates & Risk of Stress Fractures

- Reuters

09/27/2010 - European drugs regulators said they had started a safety review of a class of osteoporosis bone drugs called bisphosphonates after studies suggested a possible link to stress fractures.

The review by the European Medicines Agency follows a statement from the U.S. Food and Drug Administration earlier this month, which said it may require bisphosphonates to carry new information related to unusual femur fractures.

The bisphosphonate class includes Fosamax, made by Merck & Co and sold generically under the chemical name alendronate, Roche's Boniva, Novartis's Reclast, and Warner Chilcott's Actonel.

EMA said its Committee for Medicinal Products for Human Use (CHMP) would now review all available data thoroughly to clarify the links and "assess their impact on the balance of risks and benefits of these medicines."

"The Committee has begun looking at the possible increased risk of atypical stress fractures in patients taking bisphosphonate-containing medicines for the treatment and prevention of bone disorders," it said in a statement on Friday.

It said the review was prompted by research studies suggesting that atypical, or unusual, stress factures may be a class effect of bisphosphonates.

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