引 致 更 改 給 病 人 的 產 品 資 訊 的 藥 物 不 良 反 應 警 示
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| US FDA Drug Safety Communication: Reduced effectiveness of Plavix (clopidogrel) in patients who are poor metabolizers of the drug (English only) |
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The U.S. Food and Drug Administration (FDA) added a boxed warning to the anti-blood clotting drug Plavix (clopidogrel), alerting patients and health care professionals that the drug can be less effective in people who cannot metabolize the drug to convert it to its active form. Plavix reduces the risk of heart attack, unstable angina, stroke, and cardiovascular death in patients with cardiovascular disease by making platelets less likely to form blood clots. Plavix does not have its anti-platelet effects until it is metabolized into its active form by the liver enzyme, CYP2C19. People who have reduced functioning of their CYP2C19 liver enzyme cannot effectively convert Plavix to its active form. As a result, Plavix may be less effective in altering platelet activity in those people. These “poor metabolizers” may not receive the full benefit of Plavix treatment and may remain at risk for heart attack, stroke, and cardiovascular death. Please refer to the following links in FDA for details:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm204253.htm
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm203888.htm
Plavix and other products containing clopidogrel are available in HK. Plavix is registered by Sanofi-Aventis Hong Kong Limited, and its package insert regarding the above safety information is being updated. For other products containing clopidogrel, the above issue will be considered in the upcoming meeting of the Registration Committee in April.
Ends/Monday, March 15, 2010
Issued at HKT 15:30 |
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