6 ADVERSE REACTIONS Bleeding, including life-threatening and fatal bleeding, is the most commonly reported adverse reaction. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Torrent Pharma Inc. at 1-800-912-9561 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. The following serious adverse reactions are discussed below and elsewhere in the labeling: Bleeding [see Warnings and Precautions ( 5.2 )] Thrombotic thrombocytopenic purpura [see Warnings and Precautions ( 5.4 )]
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions and durations of follow-up, 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. Clopidogrel tablets has been evaluated for safety in more than 54,000 patients, including over 21,000 patients treated for one year or more. The clinically important adverse reactions observed in trials comparing clopidogrel tablets plus aspirin to placebo plus aspirin and trials comparing clopidogrel tablets alone to aspirin alone are discussed below. Bleeding CURE In CURE, clopidogrel tablets use with aspirin was associated with an increase in major bleeding (primarily gastrointestinal and at puncture sites) compared to placebo with aspirin (see Table 1). The incidence of intracranial hemorrhage (0.1%) and fatal bleeding (0.2%) were the same in both groups. Other bleeding events that were reported more frequently in the clopidogrel group were epistaxis, hematuria, and bruise. The overall incidence of bleeding is described in Table 1. Table 1: CURE Incidence of Bleeding Complications (% patients) * Life-threatening and other major bleeding. † Led to interruption of study medication. Event Clopidogrel tablets (+ aspirin) (n=6,259) Placebo (+ aspirin) (n=6,303) Major bleeding * 3.7
2.7 Life-threatening bleeding 2.2
1.8 Fatal 0.2 0.2 5 g/dL hemoglobin drop 0.9
0.9 Requiring sur... [See full FDA label]
