Plavix long-term treatment does not change risk of death, says FDA

A US Food and Drug Administration review released on Friday has determined that long-term use of the blood-thinning drug Plavix (clopidogrel) does not increase or decrease overall risk of death in patients with, or at risk for, heart disease.

The FDA evaluation of the Dual Antiplatelet Therapy (DAPT) trial and several other clinical trials also does not suggest that clopidogrel, French pharma major Sanofi’s (Euronext: SAN) now off-patent but once block-buster drug Plavix, increases the risk of cancer or death from cancer.

In order to investigate the increased risk of death and cancer-related death reported with clopidogrel in the DAPT trial, the FDA examined the results of the DAPT trial and other large, long-term clinical trials of clopidogrel with data available on rates of death, death from cancer, or cancer reported as an adverse event.