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FDA Panel Backs Limits on Osteoporosis Drugs | cialis online

FDA Panel Backs Limits on Osteoporosis Drugs

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An advisory committee to the U.S. Food and Drug Administration (FDA) has suggested the agency limit how long patients can remain on bisphosphonate therapy for their osteoporosis. The committee was unable, however, to agree on what that limit should be, said ABC News.

The Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee discussed if the FDA should change its label to indicate that the drugs should not be used long term. The Committee agreed a label change is in order, but, despite 17-to-6 votes for, said ABC News, the Committee was unable to agree on a timeframe, claiming insufficient data.

Last week, the FDA staff said in a report released ahead of the meeting that oral bisphosphonates, which include the dugs Fosamax, Actonel, Boniva, and Reclast do not need to be taken beyond five years to prevent broken bones from osteoporosis, .

The drugs are associated with some serious side effects, including Osteonecrosis of the Jaw (dead jaw syndrome). last year, the agency included information to the “Warnings and Precautions” section of the drugs’ labels describing atypical thigh fracture risks, said NewsInferno, which also wrote that at least 300 reports of atypical thigh fractures in patients taking bisphosphonates—typically for longer than five years—were received. The FDA is also conducting a safety review of the drugs’ links to esophageal cancer.

According to the FDA, some 5 million American post-menopausal women use oral bisphosphonates, to treat and prevent osteoporosis. The drugs have also been approved to increase bone mass in men with osteoporosis, to treat and/or prevent glucocorticoid-induced osteoporosis, and to treat Paget’s disease, said NewsInferno.

While it has long been believed that Fosamax and other bisphosphonates could safely be taken indefinitely. But, the FDA has yet to conduct a broad review of the drugs’ long-term safety and efficacy. In the report released last week, FDA staff said that studies have shown no proven benefits in the first three years of treatment to prevent osteoporosis fractures; however, benefits were seen in women taking the drugs between three and five years. Women stopping the drugs after five years saw benefits similar to women who continued taking the drugs, according to the report.

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