CoPlavix Adverse Reactions

Summary of the safety profile: Clopidogrel has been evaluated for safety in more than 42,000 patients who have participated in clinical studies, including over 30,000 patients treated with clopidogrel plus Aspirin, and over 9,000 patients treated for 1 year or more. The clinically relevant adverse reactions observed in four major studies, the CAPRIE study (a study comparing clopidogrel alone to Aspirin) and the CURE, CLARITY and COMMIT studies (studies comparing clopidogrel plus Aspirin to Aspirin alone) are discussed as follows. Overall, clopidogrel 75 mg/day was similar to Aspirin 325 mg/day in CAPRIE regardless of age, gender and race. In addition to clinical studies experience, adverse reactions have been spontaneously reported.
Bleeding is the most common reaction reported both in clinical studies as well as in the post-marketing experience where it was mostly reported during the first month of treatment.
In CAPRIE, in patients treated with either clopidogrel or Aspirin, the overall incidence of any bleeding was 9.3%. The incidence of severe cases was similar for clopidogrel and Aspirin.
In CURE, there was no excess in major bleeds with clopidogrel plus Aspirin within 7 days after coronary bypass graft surgery in patients who stopped therapy more than five days prior to surgery. In patients who remained on therapy within five days of bypass graft surgery, the event rate was 9.6% for clopidogrel plus Aspirin, and 6.3% for placebo plus Aspirin.
In CLARITY, there was an overall increase in bleeding in the clopidogrel plus Aspirin group vs. the group taking Aspirin alone. The incidence of major bleeding was similar between groups. This was consistent across subgroups of patients defined by baseline characteristics, and type of fibrinolytic or heparin therapy.
In COMMIT, the overall rate of noncerebral major bleeding or cerebral bleeding was low and similar in both groups.
In TARDIS, patients with recent ischemic stroke receiving intensive antiplatelet therapy with three medicinal products (ASA + clopidogrel + dipyridamole) had more bleeding and bleeding of greater severity when compared with either clopidogrel alone or combined ASA and dipyridamole (adjusted common OR 2.54, 95% CI 2.05-3.16, p<0.0001).
Tabulated list of adverse reactions: Adverse reactions that occurred with clopidogrel alone, with Aspirin alone or with clopidogrel in combination with Aspirin either during clinical studies or that were spontaneously reported are presented in the following tables. Their frequency is defined using the following conventions: common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data). Within each system organ class, adverse reactions are presented in order of decreasing seriousness. (See Tables A and B.)

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Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions.