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Plavix (clopidogrel): Drug Safety Communication - Long-term Treatment Does Not Change Risk of Death

AUDIENCE: Cardiology, Hematology, Surgery

ISSUE: An FDA review 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. FDA evaluation of the Dual Antiplatelet Therapy (DAPT) trial and several other clinical trials also does not suggest that clopidogrel 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, 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.

FDA performed meta-analyses of other long-term clinical trials to assess the effects of clopidogrel on death rates from all causes. The results indicate that long-term (12 months or longer) dual antiplatelet therapy with clopidogrel and aspirin do not appear to change the overall risk of death when compared to short-term (6 months or less) clopidogrel and aspirin, or aspirin alone. Also, there was no apparent increase in the risks of cancer-related deaths or cancer-related adverse events with long-term treatment.

FDA is working with the manufacturers of clopidogrel to update the label to reflect the results of the mortality meta-analysis.

BACKGROUND: Clopidogrel is an antiplatelet medicine used to prevent blood clots in patients who have had a heart attack, stroke, or problems with the circulation in the arms and legs. It works by helping to keep the platelets in the blood from sticking together and forming clots that can occur with certain medical conditions.

RECOMMENDATION: Patients should not stop taking clopidogrel or other antiplatelet medicines because doing so may result in an increased risk of heart attacks and blood clots. Talk with your health care professional if you have any questions or concerns about clopidogrel.

Read the MedWatch safety alert, including a link to the Drug Safety Communication, at:

美國FDA曾於2014年11月17日發布有關長期使用雙重抗血小板藥物治療可能增加非心血管相關死亡風險之藥物安全警訊。為了進一步研究clopidogrel是否與增加死亡風險有關,美國FDA進行Dual Antiplatelet Therapy (DAPT)試驗及其他大型長期臨床試驗之整合分析,認為長期(12個月以上)使用雙重抗血小板藥物clopidogrel和aspirin治療,相較於短期 (6個月以內)或單獨使用aspirin治療,未改變整體死亡率,且也未增加癌症相關之死亡風險或副作用。此資訊將再更新於藥品仿單中。



[Posted 11/6/2015]