Another Open Thread — Featuring FDA Advisory Committee Formation: Fosmax® ONJ Review

Feel free to use the comment section to add your own items of interest, but Injury offers us this as a headliner — do go read it all:

. . . .On July 11, 2011, the Food and Drug Administration (FDA) announced that it would form an advisory committee to discuss the risks and benefits of long-term bisphosphonate use for the treatment of osteoporosis. The formation of the committee comes in light of growing evidence that bisphosphonate drugs, such as Fosamax®, prescribed to treat osteoporosis, may cause atypical femur fractures and osteonecrosis of the jaw (jawbone death). Fosamax manufacturer Merck & Co., has faced an increasing number of lawsuits from people who have suffered atypical femur fractures or jawbone death while taking Fosamax. In addition to Fosamax, the advisory committee will discuss other bisphosphonate drugs: Actonel®, Atelvia®, Boniva® and Reclast®.

Generally, the FDA convenes an advisory committee on pharmaceutical drugs to receive public input on a broad scope of complex issues including drug safety and risk. These issues typically relate to the development and implementation of a specific regulatory program or the development and implementation of a regulatory policy to approve, recall or update labeling information for a drug.

Over the past few years, there has been an increasing number of reports involving patients who suffered multiple stress fractures and low energy femoral fractures as a result of severely suppressed bone turnover potentially linked to long-term Fosamax use. Various studies have also shown that severely suppressed bone turnover may be associated with long-term Fosamax use. . . .

Now — what did YOU see this week? Add it in the comments!


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