"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"...
Miacalcin Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Miacalcin (calcitonin-salmon) is used to treat Paget's disease of bone, postmenopausal osteoporosis, or high levels of calcium in the blood (hypercalcemia). It is a man-made form of a hormone that occurs naturally in the thyroid gland. Common side effects include runny nose, nose bleeds, nasal irritation, dry nose with crusting, headache, dizziness, nausea, flushing of the face, or back pain.
The recommended dose of Miacalcin Nasal Spray in postmenopausal osteoporotic females is one spray (200 I.U.) per day administered intranasally (in the nose), alternating nostrils daily. There may be other drugs that can affect Miacalcin. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Miacalcin is used mainly in women after menopause. It is unlikely to be used during pregnancy or breast-feeding. Consult your doctor if you have any questions about this product and pregnancy or breast-feeding.
Our Miacalcin (calcitonin-salmon) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Miacalcin in Detail - Patient Information: Side Effects
You may have increased bone pain during the first few months of treatment with calcitonin injection. This is not a sign that the medication isn't working properly.
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:
- feeling light-headed, fainting; or
- muscle stiffness.
Less serious side effects may include:
- warmth, redness, itching, or tingly feeling under your skin;
- nausea, loss of appetite, stomach pain;
- skin rash or itching;
- increased urination, especially at night;
- eye pain;
- swelling in your feet; or
- swelling or irritation of the skin where an injection was given.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Miacalcin (Calcitonin-Salmon) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Miacalcin Overview - Patient Information: Side Effects
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor immediately if this unlikely but serious side effect occurs: nasal sores.
A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Miacalcin (Calcitonin-Salmon)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Miacalcin FDA Prescribing Information: 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 entire FDA prescribing information for Miacalcin (Calcitonin-Salmon) »
Additional Miacalcin Information
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