Calcitonin Salmon (Miacalcin, Fortical)

Safety Summary

Most common adverse reactions: nausea with or without vomiting (~10%), injection site inflammation (~10%), and facial/hand flushing (2-5%) (FDA Label, Section 6.1). Nausea is most evident at treatment initiation and tends to decrease with continued use. Other reported reactions: skin rashes, pruritus of ear lobes, nocturia, feverish sensation, pain in eyes, poor appetite, abdominal pain, pedal edema, salty taste (FDA Label, Section 6.1). Post-marketing reports include urticaria, arthralgia, musculoskeletal pain, hypertension, diarrhea, polyuria, dizziness, headache, paresthesia, tremor, visual disturbance (FDA Label, Section 6.2). In the Phase 2 oral formulation trial NCT01292187, abdominal discomfort (10.5% vs 2.3% placebo) and arthralgia (11.6% vs 2.3% placebo) were more common with active treatment. The FDA label contains a cancer risk warning based on a meta-analysis of 21 RCTs showing malignancy rates of 4.1% (sCT) vs 2.9% (placebo), risk difference 1.0% (95% CI 0.3-1.6%) (FDA Label, Section 6.1). Serious hypersensitivity reactions including fatal anaphylaxis have been reported; skin testing should be considered before treatment (FDA Label, Section 5.1). Hypocalcemia with tetany and seizures has been reported; correct hypocalcemia before initiating therapy (FDA Label, Section 5.2). Circulating antibodies develop in approximately 50% of Paget's disease patients after 2-18 months, sometimes leading to loss of response (FDA Label, Section 6.3). Urine sediment abnormalities (coarse granular casts) were observed in young adult volunteers at bed rest receiving injectable sCT (FDA Label, Section 5.5).