Plavix

[Clopidogrel]

In the CAPRIE trial, the incidence of patients withdrawing from treatment because of gastrointestinal adverse reactions was 3.2% for PLAVIX and 4.0% for aspirin. In the CURE trial, the incidence of patients withdrawing from treatment because of gastrointestinal adverse reactions was 0.9% for PLAVIX + aspirin compared with 0.8% for placebo + aspirin.

Rash and Other Skin Disorders

In the CAPRIE trial, the incidence of skin and appendage disorders in patients receiving PLAVIX was 15.8% (0.7% serious); the corresponding rate in aspirin patients was 13.1% (0.5% serious). In the CURE trial the incidence of rash or other skin disorders in patients receiving PLAVIX + aspirin was 4.0% compared to 3.5% for those receiving placebo + aspirin.

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In the CAPRIE trial, the overall incidence of patients withdrawing from treatment because of skin and appendage disorders adverse reactions was 1.5% for PLAVIX and 0.8% for aspirin. In the CURE trial, the incidence of patients withdrawing because of skin and appendage disorders adverse reactions was 0.7% for PLAVIX + aspirin compared with 0.3% for placebo + aspirin.

Adverse events occurring in >2.5% of patients on PLAVIX in the CAPRIE controlled clinical trial are shown below regardless of relationship to PLAVIX. The median duration of therapy was 20 months, with a maximum of 3 years.

Adverse events occurring in >2.0% of patients on PLAVIX in the CURE controlled clinical trial are shown below regardless of relationship to PLAVIX.

Other adverse experiences of potential importance occurring in 1% to 2.5% of patients receiving PLAVIX (clopidogrel bisulfate) in the CAPRIE or CURE controlled clinical trials are listed below regardless of relationship to PLAVIX. In general, the incidence of these events was similar to that in patients receiving aspirin (in CAPRIE) or placebo + aspirin (in CURE).

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