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Fosamax: FDA Conducts Review Confirming Long-Term Use Has No Benefit

January 1, 1970 · FLEMING | NOLEN | JEZ, L.L.P.

The Food and Drug Administration (FDA) has conducted a second analysis of bisphosponates, including Fosamax. In 2004, the FDA’s first analysis linkedFosamax (alendronate), a prescription drug manufactured by Merck, to osteonecrosis of the jaw (ONJ).

Now, the FDA confirms that long-term use of Fosamax and other bisphosphonates to treat osteoporosis or osteopenia has little or no benefit. The New York Times reported that women with moderate bone density and no other risk factors are unlikely to derive benefits from long term use of Fosamax, yet continued to take these medications for years. Dr. Clifford J. Rosen, an endocrinologist and researcher at the Maine Medical Center Research Institute stated, “I think a lot of people are going to come off this drug.” In The New England Journal of Medicine article,Continuing Bisphosphonate Treatment for Osteoporosis – For Whom and for How Long?, Dr. Rosen and others, estimated that 60 to 70 percent of current users should consider discontinuing using the drugs after three to five years. According to the study, women who have been diagnosed with osteopenia, a mild version of low bone density, are especially good candidates to stop taking bisphosphonates after three to five years, particularly in light of the recent safety concerns.

The New York Times article, also reported that experts are concerned that in certain cases long-term use of Fosamax and other bisphosphonates can actually lead to weaker bones and contribute to serious side effects – unusual femur fractures, esophageal cancer and osteonecrosis of the jaw (ONJ).