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Fosamax, Other Bone Drugs Set for FDA Review | cialis online

Fosamax, Other Bone Drugs Set for FDA Review

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Drugs called oral bisphosphonates, including Merck & Co.’s osteoporosis medication Fosamax, are scheduled for review by a U.S. Food and Drug Administration (FDA) advisory panel over concerns about serious adverse events. Among other things, the panel will recommend whether or not long-term used of the drugs should be limited due to their association with a rare type of femur fracture.

It was once believed that Fosamax and similar medications could be taken indefinitely. Oral bisphosphonates are widely used in the treatment of post-menopausal women at risk for osteoporosis,especially those diagnosed with low bone density, said the Wall Street Journal.Oral bisphosphonates are also prescribed for the treatment of bone diseases such as Paget’s disease. Other drugs in this class include Actonel, Boniva, Atelvia, Didronel, and Skelid.

Oral bisphosphonates are associated with some serious side effects, including osteonecrosis of the jaw (Dead Jaw Sydrome). Some evidence has also suggested that the use of oral bisphosphonates might be linked to a higher risk of esophageal cancer, though according to a Drug Safety Communication issued by the FDA over the summer, evidence of this link is so far inconclusive.

Among other things, the FDA advisory panel that is scheduled to meet on Friday will consider whether or not use of Fosamax and similar medications should be limited to a few years, or if female patients should take a so-called “drug holiday,” in which treatment is temporarily ceased. Last year, the FDA did recommend that doctors periodically revisit the use of bisphophonates in patients who had taken the drugs for more than five years over concerns about the femur fracture seen in hundreds of women, said the Journal.

Oral bisphosphonates slow the bone breakdown seen in osteoporosis by blocking, in part, the body’s process of removing and rebuilding bone tissue. However, this could also be making remaining bones brittle and likelier to fracture, explained the Journal.

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