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