"March 7, 2013 -- An FDA panel voted to stop recommending calcitonin salmon for the treatment of osteoporosis in women who are at least five years past menopause.
The committee voted 12-9 against continued marketing of the drug, citing"...
Because calcitonin is a polypeptide, the possibility of a systemic allergic reaction exists. Administration of calcitonin-salmon has been reported in a few cases to cause serious allergic-type reactions (e.g., bronchospasm, swelling of the tongue or throat, anaphylactic shock), including very rare reports of death attributed to anaphylaxis. The usual provisions should be made for the emergency treatment of such a reaction should it occur. Allergic reactions should be differentiated from generalized flushing and hypotension.
For patients with suspected sensitivity to calcitonin, skin testing should be considered prior to treatment utilizing a dilute, sterile solution of Miacalcin®(calcitonin-salmon) Injection, Synthetic. Physicians may wish to refer patients who require skin testing to an allergist. A detailed skin testing protocol is available from the Medical Services Department of Novartis Pharmaceuticals Corporation.
The incidence of osteogenic sarcoma is known to be increased in Paget's disease. Pagetic lesions, with or without therapy, may appear by X-ray to progress markedly, possibly with some loss of definition of periosteal margins. Such lesions should be evaluated carefully to differentiate these from osteogenic sarcoma.
Periodic examinations of urine sediment of patients on chronic therapy are recommended.
Coarse granular casts and casts containing renal tubular epithelial cells were reported in young adult volunteers at bed rest who were given calcitonin-salmon to study the effect of immobilization on osteoporosis. There was no other evidence of renal abnormality and the urine sediment became normal after calcitonin was stopped. Urine sediment abnormalities have not been reported by other investigators.
Carcinogenesis, Mutagenesis, and Impairment of Fertility
An increased incidence of pituitary adenomas has been observed in one-year toxicity studies in Sprague-Dawley rats administered calcitonin-salmon at dosages of 20 and 80 I.U./kg/day and in Fisher 344 rats given 80 I.U./kg/day. The relevance of these findings to humans is unknown. Calcitonin-salmon was not mutagenic in tests using Salmonella typhimurium, Escherichia coli, and Chinese Hamster V79 cells.
Teratogenic Effects - Category C
Calcitonin-salmon has been shown to cause a decrease in fetal birth weights in rabbits when given in doses 14-56 times the dose recommended for human use. Since calcitonin does not cross the placental barrier, this finding may be due to metabolic effects on the pregnant animal. There are no adequate and well-controlled studies in pregnant women. Miacalcin Injection should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
It is not known whether this drug is excreted in human milk. As a general rule, nursing should not be undertaken while a patient is on this drug since many drugs are excreted in human milk. Calcitonin has been shown to inhibit lactation in animals.
Disorders of bone in children referred to as juvenile Paget's disease have been reported rarely. The relationship of these disorders to adult Paget's disease has not been established and experience with the use of calcitonin in these disorders is very limited. There is no adequate data to support the use of Miacalcin Injection in children.
Last reviewed on RxList: 5/2/2012
This monograph has been modified to include the generic and brand name in many instances.
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