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Fortical

"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"...

Fortical

Fortical

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;
  • headache;
  • back pain; or
  • nausea.

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.

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

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
(Adverse Reactions)

SIDE EFFECTS

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 nasal spray treated patients are presented 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

Adverse Reaction Calcitonin-Salmon Nasal Spray
N=341
% of Patients
Placebo
N=131
% of Patients
Rhinitis 12.0 6.9
Symptom of Nose† 10.6 16.0
Back Pain 5.0 2.3
Arthralgia 3.8 5.3
Epistaxis 3.5 4.6
Headache 3.2 4.6
†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.

In addition, the following adverse events were reported in fewer than 3% of patients during chronic therapy with 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 calcitonin-salmon nasal spray has not been established.

Body as a whole - General Disorders: influenza-like symptoms*, fatigue*, edema (facial, peripheral, and generalized), fever

Integumentary: erythematous rash*, skin ulceration, eczema, alopecia, pruritus, increased sweating

Musculoskeletal/Collagen: arthrosis*, myalgia*, arthritis, polymyalgia rheumatica, stiffness

Respiratory/Special Senses: sinusitis*, upper respiratory tract infection*, bronchospasm*, pharyngitis, bronchitis, pneumonia, coughing, dyspnea, taste perversion, parosmia, nasal congestion, sneezing, allergic rhinitis, nasal odor, mucosal excoriation, rhinitis ulcerative

Cardiovascular: hypertension*, angina pectoris*, tachycardia, palpitation, bundle branch block, myocardial infarction

Gastrointestinal: dyspepsia*, constipation*, abdominal pain*, nausea*, diarrhea*, vomiting, flatulence, increased appetite, gastritis, dry mouth

Liver/Metabolic: cholelithiasis, hepatitis, thirst, weight increase

Endocrine: goiter, hyperthyroidism

Urinary System: cystitis*, pyelonephritis, hematuria, renal calculus

Central and Peripheral Nervous System: dizziness*, paresthesia*, vertigo, migraine, neuralgia, agitation

Hearing/Vestibular: tinnitus, hearing loss, earache

Vision: abnormal lacrimation*, conjunctivitis*, blurred vision, vitreous floater, visual disturbance

Vascular: flushing, cerebrovascular accident, thrombophlebitis

Hematologic/Resistance Mechanisms: lymphadenopathy*, infection*, anemia

Psychiatric: depression*, insomnia, anxiety, anorexia

Immune System Disorders: hypersensitivity, anaphylaxis and anaphylactic shock

Common adverse reactions associated with the use of injectable calcitonin-salmon occurred less frequently in patients treated with 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 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 Fortical (Calcitonin-Salmon (rDNA origin)) »

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Fortical - User Reviews

Fortical User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Fortical sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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