Label Changes for:

Miacalcin (calcitonin-salmon) injection

October 2009

Changes have been made to the ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- October 2009

ADVERSE REACTIONS

Dermatologic/Hypersensitivity
  • 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.
Gastrointestinal 
  • abdominal pain, diarrhea
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