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U.S. Department of Health and Human Services

Safety

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Miacalcin (calcitonin-salmon) Injection and Nasal Spray

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

 

March 2014

Summary View

WARNINGS AND PRECAUTIONS

Malignancy
  • In a meta-analysis of 21 randomized, controlled clinical trials with calcitonin-salmon (nasal spray or investigational oral formulations), the overall incidence of malignancies reported was higher among calcitoninsalmon-treated patients (4.1%) compared with placebo-treated patients (2.9%). This suggests an increased risk of malignancies in calcitonin-salmon-treated patients compared to placebo-treated patients. The benefits for the individual patient should be carefully considered against possible

ADVERSE REACTIONS

Malignancy
  • A meta-analysis of 21 randomized, controlled clinical trials with calcitonin-salmon (nasal spray or investigational oral formulations) was conducted to assess the risk of malignancies in calcitonin-salmon-treated patients compared to placebo-treated patients. The trials in the meta-analysis ranged in duration from 6 months to 5 years and included a total of 10883 patients (6151 treated with calcitonin-salmon and 4732 treated with placebo)….

 

April 2012

Summary View

Miacalcin (Calcitonin-Salmon) Nasal Spray and Injection
*Tremors
 

ADVERSE REACTIONS

Dermatologic/Hypersensitivity
Central and Peripheral Nervous System:
  • Tremor

  

October 2009 

Summary View

 

Miacalcin (Calcitonin-Salmon) Injection

 

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