US FDA to review safety of long term use of common bisphosphonate osteoporosis drugs

12 March 2010

The US Food and Drug Administration says that it will investigate whether a link exists between the long-term use of certain osteoporosis drugs used to treat post-menopausal women and a particular type of leg fracture, following reports by the ABC News of the possible connection, but says that no such problems have been confirmed to date.

The review involves a class of drugs known as bisphosphonates, which are commonly prescribed to treat osteoporosis and are designed to build bone mass. Drugs in the class include Actonel (risedronate), marketed by Sanofi Aventis and Procter & Gamble; Boniva (ibandronate), marketed by Roche and GlaxoSmithKline, Merck & Co's Fosamax (alendronate) and Novartis' Reclast (zoledronic acid). Some studies have shown that the bones of some women stop rejuvenating after five or so years on such a drug and become brittle.
According to a recent report from Global Industry Analysts, bisphosphonates account for lion's share of the worldwide osteoporosis therapeutics market, which was is expected to cross $6.1 billion value mark in 2009.

In its announcement, the FDA said that patients and health care professionals may have questions about oral bisphosphonate medications and atypical subtrochanteric femur fractures - fractures in the bone just below the hip joint.

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