FDA to decide fate of calcitonin salmon for treating osteoporosis

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The FDA warns in a March 1, 2013 press release there may be a cancer risk from products containing calcitonin, made from a hormone contained in salmon. The fate of marketing the drugs for treating osteoporosis will be determined.
Osteoporosis, or brittle bones, raises a person’s risk of fracture and disability. Women and men can develop the disease and after menopause women are at higher risk from declining estrogen levels.
Miacalcin injection, marketed by Novartis and Unigene Laboratories Inc’s nasal spray are products containing calcitonin in the U.S. Calcitonin can also be purchased generically.
European regulatory committees have already recommended against use of the drug for osteoporosis treatment. The exception to its use is short-term for severe cases of bone loss from Paget’s disease, bone demineralization that can come from prolonged immobility and for high levels of calcium that can be cause by certain types of cancer.

The review was initiated due to concerns that the unlicensed oral preparations of calcitonin raised prostate cancer risk, based on two preliminary studies conducted in 2010.
The highest risk of osteoporosis comes from inactivity, menopause and advanced age. The condition can be painful and lead to spontaneous spine fractures that can happen with minimal exertion, such as coughing or lifting when bone loss is severe.
The disease primarily affects the spine, hip and femur neck (the long bone in the leg).
A non-invasive bone mineral density test can reveal the presence of bone loss. Weight bearing exercises and diet are lifestyle changes that can help prevent the disease that affects 9 percent of adults over age 50, according to the Centers for Disease Control (CDC).
Calcitonin salmon works in the body by regulating calcium to protect from bone loss. In 2009, the FDA issued a warning that Miacalcin injection and spray can cause tongue swelling from anaphylaxis with a “few” reports of death.
The hormone's effect for osteoporosis was discovered by Dr. Douglas Harold Copp who studied the effect of radiation on bone health, leading to use of the drug in every country in the world.
There are also questions about whether the drugs are even effective, yet the medications garnered about $14 million in sales last year.
Health Canada has also brought the drugs under scrutiny, beginning in July, 2012.
According to the European Medicines Agency review, risk of cancer from long-term use of calcitonin salmon was 0.7 percent higher for people taking oral preparations and 2.4 percent higher for those using nasal spray. The committee decided the risks of the drug outweighed any benefits for treating osteoporosis. Whether or not the FDA aligns with the European Medicine Agency remains to be seen and will be decided March 5.

Update: The FDA has decided calcitonin salmon should not be used to treat osteoporosis.