Desferal (Deferoxamine Mesylate) - Side Effects and Adverse Reactions

ADVERSE REACTIONS

The following adverse reactions have been observed, but there are not enough data to support an estimate of their frequency.

At the Injection Site:    Localized irritation, pain, burning, swelling, induration, infiltration, pruritus, erythema, wheal formation, eschar, crust, vesicles, local edema. Injection site reactions may be associated with systemic allergic reactions (see Body as a Whole, below).

Hypersensitivity Reactions and Systemic Allergic Reactions:   Generalized rash, urticaria, anaphylactic reaction with or without shock, angioedema.

Body as a Whole: Local injection site reactions may be accompanied by systemic reactions like arthralgia, fever, headache, myalgia, nausea, vomiting, abdominal pain, or asthma.

      Rare infections with Yersinia and Mucormycosis have been reported in association with Desferal use (see PRECAUTIONS).

Cardiovascular:  Tachycardia, hypotension, shock.

Digestive:    Abdominal discomfort, diarrhea, nausea, vomiting.

Hematologic:   Blood dyscrasia (e.g., cases of thrombocytopenia and/or leukopenia have been reported. A causal relationship has not been clearly established).

Musculoskeletal:   Leg cramps. Growth retardation and bone changes (e.g., metaphyseal dysplasia) are common in chelated patients given doses above 60 mg/kg, especially those who begin iron chelation in the first three years of life. If doses are kept to 40 mg/kg or below, the risk may be reduced (see WARNINGS, PRECAUTIONS/Pediatric Use).

Nervous S ystem:  Neurological disturbances including dizziness, peripheral sensory, motor, or mixed neuropathy, paresthesias; exacerbation or precipitation of aluminum-related dialysis encephalopathy (see PRECAUTIONS/Information for Patients).

Special Senses: High-frequency sensorineural hearing loss and/or tinnitus are uncommon if dosage guidelines are not exceeded and if dose is reduced when ferritin levels decline. Visual disturbances are rare if dosage guidelines are not exceeded. These may include decreased acuity, blurred vision, loss of vision, dyschromatopsia, night blindness, visual field defects, scotoma, retinopathy (pigmentary degeneration), optic neuritis, and cataracts (see WARNINGS).

Respiratory:   Acute respiratory distress syndrome (with dyspnea, cyanosis, and/or interstitial infiltrates) (see WARNINGS).

Skin:   Very rare generalized rash.

Urogenital:  Dysuria, impaired renal function (see CONTRAINDICATIONS).

REPORTS OF SIDE EFFECTS / ADVERSE REACTIONS RELATED TO DESFERAL

Possible Desferal side effects / adverse reactions in 39 year old female

Reported by a physician from France on 2007-02-07

Patient: 39 year old female

Reactions: Rheumatoid Arthritis, Autoimmune Disorder

Suspect drug(s):
Desferal

Other drugs received by patient: Didronel; Climaston

Possible Desferal side effects / adverse reactions in 25 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2007-02-09

Patient: 25 year old male weighing 50.0 kg (110.0 pounds)

Reactions: Dilatation Ventricular, Angina Unstable, Deafness, Hepatic Failure, Headache, Pyrexia, Tricuspid Valve Incompetence, Cardiomegaly, Palpitations, Myocarditis, Haemochromatosis, Cardiac Failure Congestive, Electrocardiogram ST Segment Abnormal, Back Pain, Urine Output Decreased, Hypotension, Hypoaesthesia, Cardiomyopathy, Breath Sounds Abnormal, Ventricular Dysfunction, Biopsy Heart Abnormal, Drug Eruption, Atelectasis, Hepatitis C, Serum Ferritin Increased, Chest X-RAY Abnormal, Multi-Organ Failure, Ventricular Hypertrophy, Fatigue, Cardio-Respiratory Arrest, Dialysis, Photophobia, Chest Pain, Musculoskeletal Stiffness, Pleural Effusion, Catheterisation Cardiac Abnormal, Fluid Overload, Dyspnoea, Atrial Flutter, Blood Potassium Increased, Arrhythmia, Renal Failure, Dilatation Atrial, Ejection Fraction Decreased, Mitral Valve Incompetence, Atrioventricular Block, Haemosiderosis, Nuclear Magnetic Resonance Imaging Abnormal, Leukocytosis, Sinus Tachycardia

Adverse event resulted in: death, hospitalization

Suspect drug(s):
Desferal
    Dosage: 500 mg/kg, unk
    Indication: Chelation Therapy
    Start date: 2006-06-16

Exjade
    Dosage: 1000 mg, qd
    Administration route: Oral
    Indication: Chelation Therapy
    Start date: 2006-03-23
    End date: 2006-06-19

Other drugs received by patient: Folic Acid; Hydroxyurea

Possible Desferal side effects / adverse reactions in 26 year old female

Reported by a physician from United Kingdom on 2007-02-22

Patient: 26 year old female

Reactions: Ejection Fraction Decreased, Nuclear Magnetic Resonance Imaging Abnormal

Suspect drug(s):
Desferal
    Indication: Thalassaemia

Desferal
    Dosage: 4 g, qd
    Start date: 2006-10-01

Exjade
    Dosage: unk, unk
    Indication: Thalassaemia
    End date: 2006-10-01