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.
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 (thrombocytopenia, leucopenia).
Hepatic: Increased transaminases, hepatic dysfunction.
Musculoskeletal:
Muscle spasms. 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, seizures; 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, acute renal failure, increased serum creatinine and renal tubular disorders (see CONTRAINDICATIONS and WARNINGS).
Postmarketing Reports
There are postmarketing reports of deferoxamine-associated renal dysfunction, including renal failure. Monitor patients for changes in renal function (e.g., increased serum creatinine).
|
REPORTS OF SUSPECTED DESFERAL SIDE EFFECTS / ADVERSE REACTIONS
Below is a sample of reports where side effects / adverse reactions may be related to Desferal. The information is not vetted and should not be considered as verified clinical evidence.
Possible Desferal side effects / adverse reactions in 13 year old male
Reported by a health professional (non-physician/pharmacist) from Germany on 2011-10-03
Patient: 13 year old male weighing 46.6 kg (102.5 pounds)
Reactions: Blood Alkaline Phosphatase Increased, Vomiting, Blood Creatine Phosphokinase Increased, Encephalopathy, Muscle Rigidity, Delirium
Adverse event resulted in: hospitalization
Suspect drug(s):
Desferal
Other drugs received by patient: Exjade
Possible Desferal side effects / adverse reactions in 79 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2011-12-21
Patient: 79 year old male
Reactions: Neoplasm Malignant
Adverse event resulted in: death
Suspect drug(s):
Desferal
Exjade
Dosage: 1000 mg, qd, oral
Administration route: Oral
Indication: Haematopoietic Neoplasm
Start date: 2009-02-03
End date: 2010-11-15
Exjade
Dosage: 1000 mg, qd, oral
Administration route: Oral
Indication: Lymphatic System Neoplasm
Start date: 2009-02-03
End date: 2010-11-15
Possible Desferal side effects / adverse reactions in 61 year old female
Reported by a physician from Japan on 2011-12-23
Patient: 61 year old female
Reactions: C-Reactive Protein Increased, Neoplasm Malignant, Condition Aggravated, Myelodysplastic Syndrome, Pyrexia, Infection
Adverse event resulted in: hospitalization
Suspect drug(s):
Desferal
|