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Spangenberg Shibley & Liber, LLP | Jul 10, 2012

FDA Advisory Panel Reviews Long-Term Use of Fosamax and Other Bone Drugs

Last week, two FDA advisory panels considered whether to recommend to women to discontinue the use of bone drugs called bisphosphonates. The concern stems from possible side effects from long-term use of bisphosphonates, most notably Fosamax. The decision by the FDA could affect as many as four million women in the U.S. alone.

Specifically, the panels conducted a safety review of bisphosphonates in order to determine whether the bone drugs are safe to take longer than three to five years. Evidence has been found linking long-term bisphosphonate use to odd femur breaks, bone disease in the jaw and potentially esophageal cancer.

Last year the FDA ordered bisphosphonate manufacturers to add warnings regarding increased risk of femur fractures to their labels. Warnings regarding a jaw disease called osteonecrosis were added in 2005.

The most prominent bisphosphonate, Fosamax, was approved in 1995 to treat bone weakening medical conditions such as Paget's disease of the bone and postmenopausal osteoporosis. Generic forms of Fosamax have become readily available since the Fosamax patent expired in 2008. However, bisphosphonates are still big business, with sales of $7.6 billion worldwide last year.

The makers of Fosamax, Merck, are currently facing numerous lawsuits regarding these possible side effects. In a quarterly report, Merck disclosed that it is defending against 535 suits regarding atypical femur breaks and 1,115 jaw damage suits. If you, or a loved one, has suffered a jaw or femur injury while taking Fosamax, an experienced attorney can advise you of your rights and options.

Source: FDA to Review Safety of Popular Bone Drugs