Long-Term Plavix Use Does Not Increase Death Risk

The FDA has concluded that long-term use of clopidogrel does not increase or decrease the risk of death for patients with heart disease.

The FDA has concluded that long-term use of clopidogrel (Plavix) does not increase or decrease the risk of death for patients with heart disease.

A review of the Dual Antiplatelet Therapy (DAPT) trial did not suggest that Plavix increased the risk of cancer or death from cancer, as well, according to the FDA.

Beyond examining the DAPT trial, the FDA also analyzed other large, long-term clinical trials of Plavix that had available data on rates of death or cancer. Additionally, the FDA performed meta-analyses of other clinical trials to assess the effects of Plavix on death rates from all causes.

The FDA’s review determined that dual antiplatelet therapy with Plavix and aspirin did not seem to change the overall risk of death when compared with short-term use (6 months or less) of Plavix and aspirin or aspirin alone.

“FDA is working with the manufacturers of clopidogrel to update the label to reflect the results of the mortality meta-analysis,” the administration wrote in a news release.