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
