The FDA's meta-analyses, following results of the DAPT trial in 2014, have found no association between treatment with the blood thinner clopidogrel (Plavix) and increased incidence of, or death due to, cancer.
The FDA has announced that the blood thinning agent, clopidogrel (Plavix), neither increases the risk of cancer or death from cancer, or affect the overall risk of death in patients with heart disease.
The FDA review was the consequence of results from the Dual Antiplatelet Therapy Trial (DAPT), which compared treatment with dual antiplatelet therapy (clopidogrel or prasugrel) for 12 months versus 30 months, in patients with a drug-eluting coronary stent. The study, published in the New England Journal of Medicine, patients being delivered clopidogrel for 30 months had lower rates of heart attacks and stent thrombosis, but presented with increased deaths from cancer or trauma. After the paper was published online, the FDA issued a safety alert on the drugs, with the declaration that the agency believed the benefits of both clopidogrel and prasugrel outweight their potentia risks when used for approved use.
To follow-up on these reported results, the FDA conducted meta-analyses by pooling data from DAPT and from other large, long-term trials of clopidogrel that had data on rates of death, death from cancer, or where cancer was reported as an adverse event. The analysis, which included 56,799 patients, found no difference in all-cause death between long-term clopidogrel and aspirin (6.7%) and short-term clopidogrel and aspirin or aspirin alone (6.6%). Incidence of cancer adverse events was also comparable between the 2 groups: 4.2% with long-term use and 4.0% with short-term use or with aspirin alone, as was incidence of cancer death (0.9% vs 1.1%, respectively).
While announcing that they are working with the drug's manufacturers to update the label to reflect the results of the meta-analyses, the FDA has adviced patients and healthcare providers to report any adverse events associated with the drug to the FDA MedWatch program.