March 5 A panel of advisers to the U.S. Food and
Drug Administration recommended on Tuesday that the agency no
longer support the marketing of calcitonin salmon as a treatment
for osteoporosis in post-menopausal women.
The panel voted 12-9 that the benefit of calcitonin salmon
products in treating bone-thinning associated with osteoporosis
is outweighed by a potential increase in the risk of cancer.
Calcitonin salmon is a man-made version of the hormone
calcitonin that is found in salmon.
Calcitonin products include Novartis AG's
Miacalcin injection and nasal spray and Unigene Laboratories
Inc's nasal spray. Privately held Upsher Smith
Laboratories Inc distributes Unigene's product in the United
States. Generic calcitonin products are also available.
The panel voted 20-1 that companies developing new
calcitonin salmon products must prove they are effective in
reducing fracture risk.
The result follows an FDA staff review that found
significant questions remain over whether calcitonin salmon is
effective in reducing fractures.
Last July, European regulators recommended that long-term
use of calcitonin be curtailed after a review found evidence of
a small increased risk of cancer with long-term use of the
They ruled that the benefits of calcitonin-containing
medicines did not outweigh their risks in the treatment of
osteoporosis and that they should no longer be used for this
They recommended that the drugs should only be authorized
for short-term use in Paget's disease, a bone disorder; for
acute bone loss due to sudden immobilization; and for excess
calcium in the blood caused by cancer.