FDA finds clopidogrel does not increase or decrease the risk of death in patients with heart disease

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After an extensive review, the FDA found that the long-term use of clopidogrel does not increase or decrease the overall risk of death in patients with or at risk for heart disease.

The FDA, which released its  findings on Nov. 6, also said clopidogrel does not increase or decrease the risk of cancer or death from cancer.

Clopidogrel, an antiplatelet medication, is used to reduce the risk of heart attacks, strokes and other clot-related conditions in patients who have had a previous heart attack, stroke or problems with the circulation in the arms and legs.

Researchers analyzed the Dual Antiplatelet Therapy trial that compared the use of dual antiplatelet therapy for 12 months and 30 months in patients who had received a drug-eluting coronary stent. Patients who received clopidogrel for 30 months had lower rates of heart attacks and stent thrombosis and higher rates of death.

They also conducted a meta-analysis of other long-term trials and found that patients taking dual antiplatelet therapy with clopidogrel and aspirin for at least 12 months had similar risks of death, cancer-related deaths and cancer-related adverse events when compared with 6 months or fewer treatment.

The overall incidence of death was 6.7 percent in patients taking long-term clopidogrel plus aspirin and 6.6 percent in patients receiving short-term clopidogrel plus aspirin or aspirin alone. The incidence of cancer adverse events was 4.2 percent and 4.0 percent, respectively, while the incidence of cancer death was 0.9 percent and 1.1 percent, respectively.

The FDA said it was working with clopidogrel’s manufacturers to update the drug’s label to include the results of the meta-analysis.