FDA最新消息

FDA最新消息 （10.03.12） 日期：2010-3-13 19:21:44 作者：翻译：XS 人气：1712 [大 中 小] For Immediate Release: March 12, 2010 -及时发布：2010年3月12日 FDA Announces New Boxed Warning on Plavix -FDA宣布波立维的新黑框警示 Alerts patients, health care professionals to potential for reduced effectiveness -提醒患者，专业医护人员药物的失效可能 The U.S. Food and Drug Administration today 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. -美国食品药品管理局今天对抗凝药物波立维（氯吡格雷）增加了一个黑框警示，提醒病人和专业医护人员此药物对那些不能将其代谢转化为活性形式的人群有失效的可能。 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. -波立维通过不使血小板造成凝血而降低心脏病发作，不稳定心绞痛，脑卒中，和心血管疾病患者的心血管死亡的风险。波立维在被肝酶CYP2C19代谢转化为其活性形式前不具有抗血小板作用。 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. -体内肝酶CYP2C19机能丧失的人群不能有效地将波立维转化为其活性形式。因此，波立维可能并不能有效的改变这些人的血小板活性。这些“代谢功能不全者”可能不能够获得波立维的全部疗效并可能继续承担心脏病发作，脑卒中，和心血管死亡的风险。 “We want to highlight this warning to make sure health care professionals use the best information possible to treat their patients,” said Mary Ross Southworth, Pharm.D., a clinical analyst in the Division of Cardiovascular and Renal Products in the FDA’s Center for Drug Evaluation and Research. -“我们希望强调这一警示，以确保专业医护人员用尽可能最佳的信息来治疗他们的病人。” FDA药品评估和研究中心的心血管和肾功能药物分部的临床员，药学博士，Mary Ross Southworth说到。 In May 2009, the FDA added this warning to the drug’s label. After reviewing more data, the agency felt it was important to highlight this risk in a boxed warning. -2009年5月，FDA将这条警示加入药品的标签。在审查了更多的资料后，该机构认识到在黑框警示中强调这个风险是必要的。 It is estimated that 2 percent to 14 percent of the U.S. population are poor metabolizers. The FDA recommends that health care professionals consider alternative dosing of Plavix for these patients, or consider using other anti-platelet medications. Tests are available to assess CYP2C19 genotype to determine if a patient is a poor metabolizer. -据估计，百分之二至十四的美国人是代谢功能不全者。FDA建议专业医护人员考虑选择让这些病人服用波立维或者选择考虑使用其他抗血小板药。有试验可以用于评定CYP2C19基因型用于确认其是否为代谢功能不全患者。 Patients should not stop taking Plavix unless told to do so by their health care professional. They should talk with their health care professional if they have any concerns about Plavix. -患者不应停止服用波立维，除非是他们的专业医护人员告知其需这样做时。当他们对波立维有任何疑虑时应该与其专业医护人员交谈。 Plavix is made under a Bristol-Myers Squibb - Sanofi Pharmaceuticals partnership. -波立维由百时美施贵宝和赛诺菲合作销售。