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Osteoporosis Drug Gets a Thumbs Down from FDA Review Panel

by Raja Nandhini on March 8, 2013 at 2:40 AM
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 Osteoporosis Drug Gets a Thumbs Down from FDA Review Panel

Recently an advisory committee has advised FDA to withdraw its support to market the drug, Calcitonin salmon, which is used to treat osteoporosis in postmenopausal women, after reviewing the risk factors and benefits of the drug.

Calcitonin salmon, commonly available as a nasal spray, is a synthetic equivalent of calcitonin hormone naturally found in salmon fish. Calcitonin salmon is said to prevent bone fracture and help increase bone density.

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The panel after reviewing more than 20 clinical trials found that the risk of cancer was consistent in most of the studies. It was also noted that the drug was not very efficient in preventing bone fractures.

Although the risk of cancer was not very profound, the poor efficacy of the drug led the panel members to vote 9-12 against the continued use of the drug.
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However, the drug is beneficial for short term-treatment and for patients who are allergic to other alternate drugs.

The committee members also voted 20-1 that companies developing new Calcitonin salmon products must prove the efficiency of the drug in preventing fractures.

FDA is yet to make its decision following the report of the review committee.

Source: Medindia
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