"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 a man-made form of a hormone that occurs naturally in the thyroid gland used to treat Paget's disease of bone, postmenopausal osteoporosis, or high levels of calcium in the blood (hypercalcemia). Common side effects of Miacalcin include runny nose, nose bleeds, nasal irritation, dry nose with crusting, headache, dizziness, nausea, vomiting, loss of appetite, stomach pain, flushing of the face (warmth, redness, itching, or tingly feeling under your skin), skin rash or itching, increased urination (especially at night), eye pain, swelling in your feet, back pain, and swelling or irritation of the skin where the injection was given.
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
Runny nose, nose bleeds, nasal irritation, dry nose with crusting, headache, dizziness, nausea, flushing of the face, or back pain may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.
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 right away if you have any serious side effects, including: nasal sores, muscle cramps/spasms, numbness/tingling of the arms/legs.
Get medical help right away if you have any very serious side effects, including: seizures.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: 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 following serious adverse reactions are discussed in greater detail in other sections of the label:
- Hypersensitivity Reactions, including anaphylaxis [see WARNINGS AND PRECAUTIONS]
- Hypocalcemia [see WARNINGS AND PRECAUTIONS]
- Malignancy [see WARNINGS AND PRECAUTIONS]
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of calcitonin-salmon injection was assessed in open-label trials several months to two years in duration. The most common adverse reactions are discussed below.
Nausea with or without vomiting has been noted in about 10% of patients treated with calcitonin-salmon. It is most evident when treatment is first initiated and tends to decrease or disappear with continued administration.
Local inflammatory reactions at the site of subcutaneous or intramuscular injection have been reported in about 10% of patients. Flushing of face or hands occurred in about 2%-5% of patients. Skin rashes and pruritus of the ear lobes have also been reported.
Other Adverse Reactions
Nocturia, feverish sensation, pain in the eyes, poor appetite, abdominal pain, pedal edema, and salty taste have been reported in patients treated with calcitonin-salmon injection.
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). The overall incidence of malignancies reported in these 21 trials was higher among calcitonin-salmon-treated patients (254/6151 or 4.1%) compared with placebo-treated patients (137/4732 or 2.9%). Findings were similar when analyses were restricted to the 18 nasal spray only trials [calcitonin-salmon 122/2712 (4.5%); placebo 30/1309 (2.3%)].
The meta-analysis results suggest an increased risk of overall malignancies in calcitonin-salmon-treated patients compared to placebo-treated patients when all 21 trials are included and when the analysis is restricted to the 18 nasal spray only trials (see Table 1). It is not possible to exclude an increased risk when calcitonin-salmon is administered by the subcutaneous, intramuscular, or intravenous route because these routes of administration were not investigated in the meta-analysis. The increased malignancy risk seen with the meta-analysis was heavily influenced by a single large 5-year trial, which had an observed risk difference of 3.4% [95% CI (0.4%, 6.5%)]. Imbalances in risks were still observed when analyses excluded basal cell carcinoma (see Table 1); the data were not sufficient for further analyses by type of malignancy. A mechanism for these observations has not been identified. Although a definitive causal relationship between calcitonin-salmon use and malignancies cannot be established from this meta-analysis, the benefits for the individual patient should be carefully evaluated against all possible risks [see WARNINGS AND PRECAUTIONS].
Table 1: Risk Difference for Malignancies in
Calcitonin-Salmon-Treated Patients Compared with Placebo-Treated Patients
|Patients||Malignancies||Risk Difference1 (%)||95% Confidence Interval2 (%)|
|All (nasal spray + oral)||All||1.0||(0.3, 1.6)|
|All (nasal spray + oral)||Excluding basal cell carcinoma||0.5||(-0.1, 1.2)|
|All (nasal spray only)||All||1.4||(0.3, 2.6)|
|All (nasal spray only)||Excluding basal cell carcinoma||0.8||(-0.2, 1.8)|
|1The overall adjusted risk difference is the difference
between the percentage of patients who had any malignancy (or malignancy
excluding basal cell carcinoma) in calcitonin-salmon and placebo treatment
groups, using the Mantel-Haenszel (MH) fixed-effect method. A risk difference
of 0 is suggestive of no difference in malignancy risks between the treatment
2The corresponding 95% confidence interval for the overall adjusted risk difference also based on MH fixed-effect method.
Because postmarketing adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
The following adverse reactions have been reported during post-approval use of Miacalcin injection.
Allergic / Hypersensitivity Reactions: Serious hypersensitivity reactions have been reported in patients receiving calcitonin-salmon injection, e.g., bronchospasm, swelling of the tongue or throat, anaphylactic shock, and death due to anaphylaxis.
Skin and subcutaneous tissue disorders: Urticaria
Body as a Whole: influenza-like symptoms, fatigue, edema (facial, peripheral, and generalized)
Musculoskeletal: arthralgia, musculoskeletal pain
Gastrointestinal: abdominal pain, diarrhea
Urinary System: polyuria
Vision: visual disturbance
Consistent with the potentially immunogenic properties of medicinal products containing peptides, administration of Miacalcin may trigger the development of anti-calcitonin antibodies. Circulating antibodies to calcitonin-salmon after 218 months of treatment have been reported in about one-half of the patients with Paget's disease in whom antibody studies were done. In some cases, high antibody titers are found; these patients usually will have a loss of response to treatment [see WARNINGS AND PRECAUTIONS].
The incidence of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of a positive antibody test result may be influenced by several factors, including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of antibodies among different calcitonin-salmon products may be misleading.
Read the entire FDA prescribing information for Miacalcin (Calcitonin-Salmon)
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