FC tab: Like all medicines, deferiprone can have side effects.
The most serious undesirable effect of deferiprone is the occurrence of a very low white blood cell count. This condition, known as severe neutropenia or agranulocytosis, has occurred in about 1 out of 100 patients who have taken deferiprone in clinical studies. A low white blood cell count can also be associated with an infection. Report immediately to the doctor any symptoms of infection such as: Fever, sore throat or flu-like symptoms.
Some of the patients enrolled in clinical studies with deferiprone developed joint pain and swelling. In most patients, the pain disappeared while still taking Ferriprox.
Some patients treated with Ferriprox have experienced some or all of the following symptoms: increase in liver enzymes, abdominal pain, nausea, vomiting, diarrhea and increase in appetite. Most patients find that these undesirable effects disappear after a few days to a few weeks of continued treatment. If patient experiences nausea or vomiting, it may help to take Ferriprox with some food.
The urine may become reddish/brown in colour. This is the most common undesirable effect of deferiprone and it is not harmful.
If the patient notices any side effects, please inform the doctor, pharmacist or the local distributing company immediately, who will in turn communicate it to the Medical Information Division at Apotex (Canada) by calling: +1 (416) 401-7780.
Oral soln: The most serious adverse reaction reported in clinical trials with deferiprone is agranulocytosis (neutrophils <0.5x10
9/l), with an incidence of 1.1% (0.6 cases per 100 patient‐years of treatment) (see Precautions). The observed incidence of the less severe form of neutropenia (neutrophils <1.5x10
9/l) is 4.9% (2.5 cases per 100 patient‐years). This rate should be considered in the context of the underlying elevated incidence of neutropenia in thalassaemia patients, particularly in those with hypersplenism.
Episodes of diarrhoea, mostly mild and transient, have been reported in patients treated with deferiprone. Gastrointestinal effects are more frequent at the beginning of therapy and resolve in most patients within a few weeks without the discontinuation of treatment. In some patients it may be beneficial to reduce the dose of deferiprone and then scale it back up to the former dose. Arthropathy events, which ranged from mild pain in one or more joints to severe arthritis with effusion and significant disability, have also been reported in patients treated with deferiprone. Mild arthropathies are generally transient.
Increased levels of serum liver enzymes have been reported in patients taking deferiprone. In the majority of these patients, the increase was asymptomatic and transient, and returned to baseline without discontinuation or decreasing the dose of deferiprone (see Precautions).
Some patients experienced progression of fibrosis associated with an increase in iron overload or hepatitis C.
Low plasma zinc levels have been associated with deferiprone, in a minority of patients. The levels normalised with oral zinc supplementation.
Neurological disorders (such as cerebellar symptoms, diplopia, lateral nystagmus, psychomotor slow down, hand movements and axial hypotonia) have been observed in children who had been voluntarily prescribed more than 2.5 times the maximum recommended dose of 100 mg/kg/day for several years. The neurological disorders progressively regressed after deferiprone discontinuation (see Dosage & Administration, Precautions and Overdosage).
Adverse reaction frequencies: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100). (See Table 2.)
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