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Fortical Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Fortical (calcitonin-salmon rDNA origin) Nasal Spray is a manmade form of a hormone secreted by the thyroid gland used to treat brittle bone disease (osteoporosis) in women who are at least 5 years past menopause. Common side effects include runny nose, nosebleeds, nasal irritation, dry nose with crusting, headache, dizziness, nausea, flushing of the face, or back pain.
The recommended dose of Fortical Nasal Spray in postmenopausal osteoporotic patients is 1 spray (200 International Units) per day administered intranasally, alternating nostrils daily. Fortical may interact with other drugs. Tell your doctor all medications and supplements you use. This medication is used mainly in women after menopause and is unlikely to be used during pregnancy or breastfeeding. Consult your doctor if you have questions.
Our Fortical (calcitonin-salmon rDNA origin) Nasal Spray 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.
Fortical in Detail - Patient Information: Side Effects
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
- severe nasal irritation.
Less serious side effects may include:
- bleeding from your nose;
- runny or stuffy nose;
- dryness, itching, tenderness, or general discomfort of your nose;
- crusting, scabs, or sores inside your nose;
- redness in or around your nose;
- warmth, redness, or tingly feeling under your skin;
- back pain; or
Read the entire detailed patient monograph for Fortical (Calcitonin-Salmon (rDNA origin)) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Fortical 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 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 Fortical (Calcitonin-Salmon (rDNA origin))»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Fortical 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]
- Nasal Adverse Reactions [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 nasal spray in the treatment of postmenopausal osteoporosis was assessed in 5 randomized, double-blind, placebo controlled trials that enrolled postmenopausal women, aged 45-75 years. The duration of the trials ranged from 1 to 2 years. The incidence of adverse reactions reported in studies involving postmenopausal osteoporotic patients chronically exposed to calcitonin-salmon nasal spray (N=341) and to placebo nasal spray (N=131), and reported in greater than 3% of calcitonin-salmon treated patients are presented in the following table. Other than flushing, nausea, possible allergic reactions, and possible local irritative effects in the respiratory tract, a relationship to calcitonin-salmon nasal spray has not been established.
Table 1: Adverse Reactions Occurring in at Least 3% of
Postmenopausal Patients Treated Chronically
|Adverse Reaction||Calcitonin-Salmon Nasal Spray
% of Patients
|Placebo Nasal Spray
% of Patients
|Symptom of Nose†||11||16|
|†Symptom of nose includes: nasal crusts, dryness, redness or erythema, nasal sores, irritation, itching, thick feeling, soreness, pallor, infection, stenosis, runny/blocked, small wound, bleeding wound, tenderness, uncomfortable feeling and sore across bridge of nose.|
Nasal Adverse Reactions: In all postmenopausal patients treated with calcitonin-salmon nasal spray, the most commonly reported nasal adverse reactions included rhinitis (12%), epistaxis (4%), and sinusitis (2%). Smoking did not have a contributory effect on the occurrence of nasal adverse reactions.
Adverse reactions reported in 1-3% of patients treated with calcitonin-salmon nasal spray include: influenza-like symptoms, erythematous rash, arthrosis, myalgia, sinusitis, upper respiratory tract infection, bronchospasm, abdominal pain, nausea, dizziness, paresthesia, abnormal lacrimation, conjunctivitis, lymphadenopathy, infection, and depression.
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 metaanalysis 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-salmontreated 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 2). 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 2); 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 2: 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
2 The 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 calcitoninsalmon nasal spray.
Allergic / Hypersensitivity Reactions: Serious allergic reactions have been reported in patients receiving calcitonin-salmon nasal spray, including anaphylaxis and anaphylactic shock.
Hypocalcemia: Hypocalcemia with paresthesia has been reported.
Body as a whole: facial or peripheral edema
Nervous system disorders: tremor
Consistent with the potentially immunogenic properties of medicinal products containing peptides, administration of Fortical may trigger the development of anti-calcitonin antibodies. In a two-year calcitonin-salmon nasal spray clinical study that evaluated immunogenicity, a measurable antibody titer was found in 69% of patients treated with calcitonin-salmon and 3% of placebo-treated patients. Antibody formation may be associated with 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 to calcitonin-salmon nasal spray with the incidence of antibodies to other calcitonin-containing products may be misleading.
Read the entire FDA prescribing information for Fortical (Calcitonin-Salmon (rDNA origin)) »
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