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Osteoporosis Drug Ineffective and Dangerous, FDA Reports

Update Date: Mar 06, 2013 09:33 AM EST
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The Food and Drug Administration voted against the use of an old osteoporosis drug that has been on the market for years. After research into the drug's effectiveness and possible side effects, the FDA voted 12 to nine in favor of stopping the sales of calcitonin salmon, the drug's chemical name. The drug is currently on the market in nasal forms as Miacalcin made by Novartis and Fortical made by Upsher-Smith. The researchers have found that the drugs may be tied to increasing the risks for developing cancer and may not be as effective as previously thought.

The chemical calcitonin salmon was retested for its effectiveness in treating brittle bones, a symptom of osteoporosis. When the drug was awaiting FDA approval, researchers found that the drug does successfully increase bone mineral density. However, there was no evidence that an increased bone mineral density prevents bone fractures, which is the main concern for people suffering from osteoporosis. Therefore, a direct link between the drug and treating osteoporosis was never found. Based from two previous studies, patients who were taking calcitonin had a higher percentage of developing cancer. This trend of higher cancer rates questioned the safety of the drug, which led to the FDA's vote.

The European Medicines Agency also concluded that the cancer risks that calcitonin leads to outweighs the supposed benefits it has on treating the disease. In July, the agency also stopped using the drug to treat osteoporosis. In the largest study ever done for studying the effectiveness of calcitonin, the results were inconclusive due to the high drop out rate. 1,200 women were a part of this study that lasted five years. As of right now, there have not been any studies stating that calcitonin is highly effective in preventing bone fractures.

The FDA also voted 20-1 in favor of approving future calcitonin drugs only if they show evidence that the drug is directly linked to treating the disease

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