"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"...
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Details with Side Effects
The incidence of adverse reactions reported in studies involving postmenopausal osteoporotic patients chronically exposed to Miacalcin® (calcitonin-salmon) Nasal Spray (N=341) and to placebo nasal spray (N=131) and reported in greater than 3% of Miacalcin (calcitonin-salmon) Nasal Spray-treated patients are presented below in the following table. Most adverse reactions were mild to moderate in severity. Nasal adverse events were most common with 70% mild, 25% moderate, and 5% severe in nature (placebo rates were 71% mild, 27% moderate, and 2% severe).
Adverse Reactions Occurring in at
Least 3% of Postmenopausal Patients Treated Chronically Miacalcin®
|Adverse Reaction||Nasal Spray
|Symptom of Nose†||10.6||16|
|† Symptom of nose includes: nasal crusts, dryness, redness or erythema, nasal sores, irritation, itching, thick feeling, soreness, pallor, infection, stenosis, runny/block ed, small wound, bleeding wound, tenderness, uncomfortable feeling and sore across bridge of nose.|
In addition, the following adverse events were reported in fewer than 3% of patients during chronic therapy with Miacalcin® (calcitonin-salmon) Nasal Spray. Adverse events reported in 1%-3% of patients are identified with an asterisk(*). The remainder occurred in less than 1% of patients. Other than flushing, nausea, possible allergic reactions, and possible local irritative effects in the respiratory tract, a relationship to Miacalcin® (calcitonin-salmon) Nasal Spray has not been established.
Body as a Whole – General Disorders: influenza-like symptoms*, fatigue*, periorbital edema, fever
Cardiovascular: hypertension*, angina pectoris*, tachycardia, palpitation, bundle branch block, myocardial infarction
Endocrine: goiter, hyperthyroidism
Hearing/Vestibular:tinnitus, hearing loss, earache
Vision: abnormal lacrimation*, conjunctivitis*, blurred vision, vitreous floater
Hematologic/Resistance Mechanisms: lymphadenopathy*, infection*, anemia
Common adverse reactions associated with the use of injectable calcitonin-salmon occurred less frequently in patients treated with Miacalcin (calcitonin-salmon) Nasal Spray than in those patients treated with injectable calcitonin. Nausea, with or without vomiting, which occurred in 1.8% of patients treated with the nasal spray (and 1.5% of those receiving placebo nasal spray) occurs in about 10% of patients who take injectable calcitonin-salmon. Flushing, which occurred in less than 1% of patients treated with the nasal spray, occurs in 2%-5% of patients treated with injectable calcitonin-salmon. Although the administered dosages of injectable and nasal spray calcitonin-salmon are comparable (50-100 units daily of injectable versus 200 units daily of nasal spray), the nasal dosage form has a mean bioavailability of about 3% (range 0.3%-30.6%) and therefore provides less drug to the systemic circulation, possibly accounting for the decrease in frequency of adverse reactions.
The collective foreign marketing experience with Miacalcin (calcitonin-salmon) Nasal Spray does not show evidence of any notable difference in the incidence profile of reported adverse reactions when compared with that seen in the clinical trials.
Read the Miacalcin (calcitonin-salmon) Side Effects Center for a complete guide to possible side effects
Formal studies designed to evaluate drug interactions with calcitonin-salmon have not been done. No drug interaction studies have been performed with Miacalcin® (calcitonin-salmon) Nasal Spray ingredients.
Currently, no drug interactions with calcitonin-salmon have been observed. The effects of prior use of diphosphonates in postmenopausal osteoporosis patients have not been assessed; however, in patients with Paget's disease prior diphosphonate use appears to reduce the anti-resorptive response to Miacalcin (calcitonin-salmon) Nasal Spray.
Periodic Nasal Examinations
Periodic nasal examinations with visualization of the nasal mucosa, turbinates, septum and mucosal blood vessel status are recommended.
The development of mucosal alterations or transient nasal conditions occurred in up to 9% of patients who received Miacalcin (calcitonin-salmon) Nasal Spray and in up to 12% of patients who received placebo nasal spray in studies in postmenopausal females. The majority of patients (approximately 90%) in whom nasal abnormalities were noted also reported nasally related complaints/symptoms as adverse events. Therefore, a nasal ex amination should be performed prior to start of treatment with nasal calcitonin and at any time nasal complaints occur.
In all postmenopausal patients treated with Miacalcin (calcitonin-salmon) Nasal Spray, the most commonly reported nasal adverse events included rhinitis (12%), epistaxis (3.5%), and sinusitis (2.3%). Smoking was shown not to have any contributory effect on the occurrence of nasal adverse events. One patient (0.3%) treated with Miacalcin (calcitonin-salmon) Nasal Spray who was receiving 400 I.U. daily developed a small nasal wound. In clinical trials in another disorder (Paget's disease), 2.8% of patients developed nasal ulcerations.
If severe ulceration of the nasal mucosa occurs, as indicated by ulcers greater than 1.5 mm in diameter or penetrating below the mucosa, or those associated with heavy bleeding, Miacalcin (calcitonin-salmon) Nasal Spray should be discontinued. Although smaller ulcers often heal without withdrawal of Miacalcin (calcitonin-salmon) Nasal Spray, medication should be discontinued temporarily until healing occurs.
Read the Miacalcin Drug Interactions Center for a complete guide to possible interactions
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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