Other safety alerts
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| The United States: Drug Safety Communication: FDA review finds long-term treatment with blood-thinning medicine Plavix (clopidogrel) does not change risk of death |
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A U.S. Food and Drug Administration (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. The FDA’s 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.
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.
Health care professionals are encourage to advise patients to report any unanticipated, prolonged, or excessive bleeding, or blood in their stools or urine. When selecting antiplatelet therapy for patients with an acute coronary syndrome who are managed with coronary stent implantation, prescribers should consider that prasugrel and ticagrelor have been shown to be superior to clopidogrel when used in this patient population. In addition, in patients with a history of myocardial infarction one to three years prior to study enrollment, ticagrelor has also been shown to reduce the risk of cardiovascular death, myocardial infarction, and stroke.
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. Patients are advised to talk with their health care professional if they have any questions or concerns about clopidogrel.
Please refer to the following website in FDA for details:
http://www.fda.gov/Drugs/DrugSafety/ucm471286.htm
In Hong Kong, there are 32 registered pharmaceutical products containing clopidogrel, and are prescription-only medicines. So far, the Department of Health (DH) has received notification of one adverse drug reaction case after taking clopidogrel, and it was not related to cancer or cancer-related death. In view of the above conclusions of the scientific review by the FDA, letter to inform local healthcare professionals will be issued. DH will continue to remain vigilant on the safety of clopidogrel.
Ends/ Saturday, November 07, 2015
Issued at HKT 12:00
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