FDA Panel Votes against Use of Osteoporosis Drug

The U.S. Food and Drug Administration has voted against the use of the drug Calcitonin Salmon that has been in use since the 1980s. They have voted 12 to 9 against the inhalable drug that is prescribed for postmenopausal women for osteoporosis. This drug is marketed as Miacalcin made by Novartis and Fortical nasal sprays made by Upsher-Smith.

Researchers reviewed the safety of the drug in two recent studies and noticed that the drug, which is used to treat bones, outweighs its benefits and increases the risk of cancer.

Apart from this, the drug is available in the form of an injection to treat other conditions such as excess calcium content in bones.

Earlier the drug was approved on the basis of a study which showed that the drug increased the bone mineral density, thereby reducing bone fractures.  The study was conducted on 1,200 women and was followed up for five years. The study showed a slightly higher rate of cancer among those who used the drug, reports The Associated Press.

What remains a fact at the present time is that the use of the drug is linked to the increased risk of cancer.

''I think the cancer risk seems to be low, but it tips the balance for this drug, which has very little evidence of efficacy,'' Amy Whitaker, a professor at the University of Chicago, was quoted as saying in The Associated Press.

Most people depend on Calcitonin Salmon as they suffer adverse affects with other new drugs such as Fosamax.

The FDA panel also voted 20-1, stating the company developing the new Calcitonin Salmon product must prove the real effectiveness, ensuring it cures the bone fractures and does not give rise to any other health problems. They state that the drug should be used to treat Paget's disease that involves abnormal bone destruction and regrowth, reports The Examiner.