The Food and Drug Administration (FDA) review was published in The New England Journal of Medicine (5/9/12) and was prompted by a lack of consensus as to how long women should use bisphosphonate medications. Bisphosphonates are used to prevent osteoporosis, but have been linked in some studies to an increased risk of atypical femur fractures and osteonecrosis of the jaw.
The analysis, which was reported on by The New York Times (5/9/12), found little benefit to using the drugs for longer than three to five years. Although there is some benefit from using the drugs for the short term, that benefit disappears after three to five years, depending on the individual. Because there are serious risks to having osteoporosis, women at risk of those serious complications, such as spinal fractures, may receive greater benefit from using bisphosphonates for longer periods.
Although the FDA issued its analysis, it did not offer many recommendations for prescribing or using bisphosphonate medications. The agency noted that women who have a low risk of osteoporosis complications could be good candidates to discontinue the medication after three to five years.
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Researchers did note that the incidence of serious side effects was relatively rare, but women should be aware that there may not be any further benefit to taking the drug for longer than three to five years.
Lawsuits have been filed against Merck, maker of Fosamax, alleging its drug is linked to an increased risk of osteonecrosis of the jaw. Merck has so far won five of six Fosamax bellwether lawsuits to make their way to court.