Five Years on Fosamax, Other Bone Drugs May be Adequate, FDA Says

<"">Fosamax, <"">Actonel, <"">Boniva and other oral bisphosphonates don’t have to be taken beyond five years in order to prevent broken bones from osteoporosis, a new U.S. Food & Drug Administration (FDA) report says. The report was released yesterday, two days before an FDA advisory panel is scheduled review the long-term safety of the popular bone drugs.

According to the FDA, approximately 5 million Americans use oral bisphosphonates. They are mostly used for the treatment and prevention of osteoporosis in post-menopausal women. Other approved indications include treatment to increase bone mass in men with osteoporosis, treatment and/or prevention of glucocorticoid-induced osteoporosis, and Paget’s disease.

The drugs are associated with some serious side effects, including Osteonecrosis of the Jaw (dead jaw syndrome). The FDA is also conducting an ongoing safety review of oral bisphosphonates and a possible link to esophageal cancer. And just last year, the FDA added information to the “Warnings and Precautions” section of the drugs’ labels describing the risk of atypical thigh fractures. As we reported previously, there have been at least 300 reports of atypical thigh fractures in patients taking bisphosphonates, often for longer than five year.

It had long been assumed that Fosamax and other bisphosphonates could safely be taken indefinitely, but as side effects have mounted, that assumption has been challenged. Unfortunately, most studies of bisphosphonates have only looked at the drugs for a few years. The FDA has never conducted a broad review of the long-term safety and efficacy of the drugs. As safety worries have grown, some doctors have begun prescribing “drug holidays” – temporary breaks – from the drugs for their bisphosphonate patients.

“The safety of long-term bisphosphonate therapy continues to be unclear as study results are conflicting,” the newly-released FDA report says. According to the report’s summary, data from an FDA-sponsored study suggest an increased prevalence of dead jaw syndrome the longer oral bisphosphonates are used, with the highest prevalence occurring at 4 or more years of use. However, the report states that the interpretation requires caution, as the study was not designed to determine causation. In regards to atypical thigh fractures, the report states that “to date suggest a strong association with bisphosphonate use, although causality has not been determined.” Finally, the report finds that a link between the drugs and esophageal cancer is “plausible,” but that data remains inconclusive so far.

In regards to the effectiveness of the drugs, the FDA staff report says studies have shown no proven benefits in preventing osteoporosis fractures for the first three years of treatment, but that benefits were seen in women who used them between three and five years. However, women who stop taking the drugs after five years experienced similar benefits to those who continued taking them, the report said.

A “drug holiday” from bisphosphonates might be warranted, the report said, but there is “no substantial data available to inform decisions regarding the initiation or duration of a drug holiday.”

According to a report from The New York Times, Merck & Co., maker of Fosamax, released its own report in advance of the FDA advisory panel meeting. “The available data support a favorable benefit to risk profile during long-term (10-year) treatment with alendronate (Fosamax) in osteoporotic patients who remain at risk of osteoporotic fracture and who have not experienced adverse reactions that required discontinuation of therapy,” the drug maker claims.

Merck did, however, support the idea of a drug holiday “for patients who have previously received long-term treatment and are no longer considered to have a sufficiently high fracture risk,” the Times said.

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