FDA Says Blood Thinner Does Not Increase Cancer Risk

Benefits of Plavix found to outweigh potential adverse events.

Benefits of Plavix found to outweigh potential adverse events.

A common blood thinning agent was not found to carry an additional threat of a potentially deadly adverse event.

The FDA announced last week that clopidogrel (Plavix) was not found to increase the risk of cancer or cancer mortality. Additionally, the overall death risk in patients with heart disease is not affected by the treatment.

The FDA review followed results from the Dual Antiplatelet Therapy Trial (DAPT) evaluating treatment with dual antiplatelet therapy (clopidogrel or prasugrel) for 12 months versus 30 months among patients with a drug-eluting coronary stent.

Published in the New England Journal of Medicine, the DAPT trial indicated that patients administered clopidogrel for 30 months had lower rates of heart attacks and stent thrombosis, but showed increased deaths from cancer or trauma.

On the heels of the findings from the trial, the FDA issued a safety alert on clopidogrel and prasugrel, indicating the potential benefits of these treatments outweigh the potential risks when used for approved use.

As part of a follow up investigation, the FDA analyzed pooling data from DAPT and from other large, long-term trials of clopidogrel with data on mortality rates, cancer death, and when cancer was reported as an adverse event.

The study of 56,799 patients showed no disparity in all-cause death between long-term use of clopidogrel and aspirin (6.7%), short-term clopidogrel and aspirin or aspirin alone (6.6%).

Incidence of cancer adverse events was similar between the 2 groups: 4.2% with long-term use and 4% with short-term use or with aspirin alone. Incidence of cancer death was also similar among the 2 groups (0.9% vs 1.1%).

The FDA said it would work with the respective manufacturers to update the label in order to reflect results from these meta-analyses. Furthermore, the FDA advises patients and health care providers to report adverse events associated with the drug to the FDA MedWatch program.