Deferiprone Side Effects

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described below and elsewhere in the labeling: Agranulocytosis and Neutropenia [see Warnings and Precautions (5.1) ] Liver Enzyme Elevations [see Warnings and Precautions (5.2) ] Zinc Deficiency [see Warnings and Precautions (5.3) ] The most common adverse reactions in patients with thalassemia (incidence > 6%) are nausea, vomiting, abdominal pain, arthralgia, ALT increased and neutropenia.

(5.1, 6) To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc., at 1-866-923-4914 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trial 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 following adverse reaction information represents the pooled data collected from single arm or active-controlled clinical trials with deferiprone tablets (three times a day).

Thalassemia Syndromes The safety of deferiprone was evaluated in the pooled clinical trial database [see Clinical Studies (14.1)] .

Patients received deferiprone tablets (three times a day).

Deferiprone was administered orally three times a day (total daily dose either 50, 75, or 99 mg/kg), N=

Among 642 patients receiving deferiprone, 492 (76.6%) were exposed for 6 months or longer and 365 (56.9%) were exposed for greater than one year.

The median age of patients who received deferiprone was 19 years (range 1, 77 years);

50.2% female;

71.2% White, 17.8% Asian, 9.2% Unknown, 1.2% Multi-racial and 0.6% Black.