FDA: No Raised Mortality, Cancer Risk With Long-Term Clopidogrel

Deborah Brauser


November 06, 2015

SILVER SPRING, MD — Using the antiplatelet clopidogrel with aspirin for over a year doesn't increase or decrease risk of overall death in patients with CHD or who are at risk for developing the disease—and it doesn't change the risk of cancer death or of developing cancer, according to an FDA MedWatch released today[1].

The announcement was based on a review of the Dual Antiplatelet Therapy (DAPT) trial, as well as of other large clinical trials that also examined adverse events from clopidogrel use. The FDA's meta-analyses of 56,799 patients showed no difference in all-cause death between clopidogrel and aspirin used for 12 months or longer (6.7% incidence) vs use of both medications or aspirin alone for 6 months or less (6.6% incidence).

Long-term use of the dual antiplatelet therapy also showed no increase in any cancer-related adverse event (4.2% vs 4.0%, respectively) or death (0.9% vs 1.1%, respectively).

The agency reported that it's working with the medication's manufacturers to update the labels of clopidogrel with these results.

Last year, the FDA announced there was a higher risk of noncardiovascular death after 30 months of use of aspirin plus clopidogrel after drug-eluting-stent implantation vs 12 months of use, based on preliminary data from DAPT[2]. However, because long-term use was also found to decrease MIs and thrombosis, the agency said it believed the treatments "continue to outweigh their potential risks when used for approved uses."

As reported by heartwire from Medscape, results released in 2010 from the TRITON-TIMI 38 trial suggested that use of prasugrel (Effient, Daiichi Sankyo/Lilly) was associated with an increased risk of cancer, although questions were brought up about the way the data were collected.

The FDA notes in today's announcement that "patients should not stop taking clopidogrel or other antiplatelet medicines because doing so may result in increased risk of heart attacks and blood clots." And it adds that healthcare professionals should weigh the benefits and risks of these medications before starting treatment.


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