FDA关于NSAIDs的说明书修改公告（中英文），国内医生不知如何看待
发布于 2005-04-14 · 浏览 792 · IP 上海上海
这个帖子发布于 20 年零 50 天前，其中的信息可能已发生改变或有所发展。
FDA新闻
2005年4月7日
美国食品药品监督管理局（FDA）宣布已上市的非甾体类抗炎药（NSAIDs）说明书需做一系列调整
FDA今日宣布目前市场上的非甾体类抗炎药物（NSAIDs），包括COX-2选择性、处方和非处方（OTC）类非选择性NSAIDs药物需做一系列的重要调整。这些药物的列表可在网站 http://www.fda.gov/cder/drug/infopage/cox2/default.htm. 上查到。
FDA药品审评研究中心执行总监Dr.StevenK.Galson说：“今天所采取的行动保护并促进了数百万每天依靠这些药物的美国人的健康。FDA基于最新的科学数据提供相关的公众信息以指导谨慎和正确地使用这类药物，使得药物的获益最大化而危险性最小。”
由于辉瑞制药公司生产的镇痛药Bextra（伐地昔布）的风险效益评估结果不理想，FDA已要求辉瑞将其产品Bextra从市场撤回。FDA还要求辉瑞在西乐葆（塞来昔布）的说明书中增加黑框警示。辉瑞公司已同意在美国暂停Bextra的销售和市场推广，并就此事与FDA进行进一步的讨论。辉瑞同意与FDA一起制定西乐葆的黑框警示。FDA同时要求所有其他NSAIDs处方药的制造商修改说明书，加上同样的黑框警示，提醒与使用这类药物相关的潜在增加心血管事件和胃肠道出血事件的风险。西乐葆以及其他所有NSAIDs处方药的生产商均被要求修订其药品说明书，增加一个用药指导，帮助病人认识使用这类药物可能引发的心血管事件和胃肠道出血事件。
而且，FDA要求所有NSAIDs OTC药物生产商修订其说明书，增加更为明确的有关潜在的心血管和胃肠道危险的信息和帮助消费者安全使用药物的信息。FDA还要求NSAIDs OTC药物生产商的说明书增加潜在的皮肤反应警示。在NSAIDs处方药上的说明书上已标明了潜在的皮肤反应警示。
目前对NSAIDs类药物的心血管风险的再评价始于默沙东去年9月份从全球自愿撤回其COX－2选择性NSAID万络（罗非昔布）之后。FDA将对默沙东公司重新上市万络的任何申请予以慎重审查。
这些行动基于目前可获得的科学数据，包括了自药物批准以来的累积数据。FDA已经认真地考虑了2005年2月16－18日召开的FDA关节炎和药物安全与危险处理咨询委员会联席会议的发言报告、讨论和推荐。
为使公众和卫生保健人员获悉这些决议，FDA今日签署了一份公共卫生建议（PHA）和最新病人与卫生保健医师情况报告。
有关FDA今日的声明的其他信息，请登陆FDA网站 http://www.fda.gov/cder/index.html. 也可以致电1-888-INFO-FDA (888-463-6332).
FOR IMMEDIATE RELEASE
P05-16
April 7, 2005
Media Inquiries: Kathleen Quinn
301-827-6242
Consumer Inquiries: 888-INFO-FDA
FDA Announces Series of Changes to the Class of Marketed Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
The Food and Drug Administration (FDA) today announced a series of important changes pertaining to the marketing of the non-steroidal anti-inflammatory class of drugs, including COX-2 selective and prescription and non-prescription (over-the-counter (OTC)) non-selective NSAID medications. A list of these products is available on the Internet at http://www.fda.gov/cder/drug/infopage/cox2/default.htm.
"Today's actions protect and advance the health of the millions of Americans who rely on these drugs everyday," said Dr. Steven K. Galson, Acting Director of FDA's Center for Drug Evaluation and Research (CDER). "FDA is providing the public information based on the latest available scientific data to guide the careful and appropriate use of these drugs aimed at maximizing their potential benefits and minimizing their risks."
FDA has asked Pfizer, Inc. to withdraw Bextra (valdecoxib) from the market because the overall risk versus benefit profile for the drug is unfavorable. FDA has also asked Pfizer to include a boxed warning in the Celebrex (celecoxib) label. Pfizer has agreed to suspend sales and marketing of Bextra in the U.S., pending further discussions with the agency. Pfizer has agreed to work with FDA on the boxed warning for Celebrex. FDA is asking manufacturers of all other prescription NSAIDs to revise their labels to include the same boxed warning highlighting the potential for increased risk of cardiovascular (CV) events and gastrointestinal (GI) bleeding associated with their use. Manufacturers of Celebrex and all other prescription NSAIDs will be asked to revise their labeling to include a Medication Guide for patients to help make them aware of the potential for CV and GI adverse events associated with the use of this class of drugs.
In addition, FDA is asking the manufacturers of all OTC NSAIDs to revise their labels to include more specific information about the potential CV and GI risks, and information to assist consumers in the safe use of the drugs. FDA is also asking manufacturers of OTC NSAIDs to include a warning about potential skin reactions. The labeling of the prescription NSAIDs already addresses potential skin reactions.
This current reexamination of the CV risks of NSAIDs began after Merck conducted a voluntary worldwide withdrawal of its COX-2 selective NSAID, Vioxx (rofecoxib), in September 2004. FDA will carefully review any proposal from Merck for resumption of marketing of Vioxx.
These actions are based on the available scientific data, including data accumulated since the drugs were approved. The FDA has carefully considered the presentations, discussions, and recommendations from the joint meeting of the Agency's Arthritis and Drug Safety and Risk Management Advisory Committee held on February 16-18, 2005.
To inform the public and healthcare community of its decisions, FDA today issued a Public Health Advisory (PHA) and updated patient and healthcare practitioner fact sheets.
Additional information about today's announcements is available on FDA's Web site at http://www.fda.gov/cder/index.html. Information can also be obtained by calling 1-888-INFO-FDA (888-463-6332).
####
2005年4月7日
美国食品药品监督管理局（FDA）宣布已上市的非甾体类抗炎药（NSAIDs）说明书需做一系列调整
FDA今日宣布目前市场上的非甾体类抗炎药物（NSAIDs），包括COX-2选择性、处方和非处方（OTC）类非选择性NSAIDs药物需做一系列的重要调整。这些药物的列表可在网站 http://www.fda.gov/cder/drug/infopage/cox2/default.htm. 上查到。
FDA药品审评研究中心执行总监Dr.StevenK.Galson说：“今天所采取的行动保护并促进了数百万每天依靠这些药物的美国人的健康。FDA基于最新的科学数据提供相关的公众信息以指导谨慎和正确地使用这类药物，使得药物的获益最大化而危险性最小。”
由于辉瑞制药公司生产的镇痛药Bextra（伐地昔布）的风险效益评估结果不理想，FDA已要求辉瑞将其产品Bextra从市场撤回。FDA还要求辉瑞在西乐葆（塞来昔布）的说明书中增加黑框警示。辉瑞公司已同意在美国暂停Bextra的销售和市场推广，并就此事与FDA进行进一步的讨论。辉瑞同意与FDA一起制定西乐葆的黑框警示。FDA同时要求所有其他NSAIDs处方药的制造商修改说明书，加上同样的黑框警示，提醒与使用这类药物相关的潜在增加心血管事件和胃肠道出血事件的风险。西乐葆以及其他所有NSAIDs处方药的生产商均被要求修订其药品说明书，增加一个用药指导，帮助病人认识使用这类药物可能引发的心血管事件和胃肠道出血事件。
而且，FDA要求所有NSAIDs OTC药物生产商修订其说明书，增加更为明确的有关潜在的心血管和胃肠道危险的信息和帮助消费者安全使用药物的信息。FDA还要求NSAIDs OTC药物生产商的说明书增加潜在的皮肤反应警示。在NSAIDs处方药上的说明书上已标明了潜在的皮肤反应警示。
目前对NSAIDs类药物的心血管风险的再评价始于默沙东去年9月份从全球自愿撤回其COX－2选择性NSAID万络（罗非昔布）之后。FDA将对默沙东公司重新上市万络的任何申请予以慎重审查。
这些行动基于目前可获得的科学数据，包括了自药物批准以来的累积数据。FDA已经认真地考虑了2005年2月16－18日召开的FDA关节炎和药物安全与危险处理咨询委员会联席会议的发言报告、讨论和推荐。
为使公众和卫生保健人员获悉这些决议，FDA今日签署了一份公共卫生建议（PHA）和最新病人与卫生保健医师情况报告。
有关FDA今日的声明的其他信息，请登陆FDA网站 http://www.fda.gov/cder/index.html. 也可以致电1-888-INFO-FDA (888-463-6332).
FOR IMMEDIATE RELEASE
P05-16
April 7, 2005
Media Inquiries: Kathleen Quinn
301-827-6242
Consumer Inquiries: 888-INFO-FDA
FDA Announces Series of Changes to the Class of Marketed Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
The Food and Drug Administration (FDA) today announced a series of important changes pertaining to the marketing of the non-steroidal anti-inflammatory class of drugs, including COX-2 selective and prescription and non-prescription (over-the-counter (OTC)) non-selective NSAID medications. A list of these products is available on the Internet at http://www.fda.gov/cder/drug/infopage/cox2/default.htm.
"Today's actions protect and advance the health of the millions of Americans who rely on these drugs everyday," said Dr. Steven K. Galson, Acting Director of FDA's Center for Drug Evaluation and Research (CDER). "FDA is providing the public information based on the latest available scientific data to guide the careful and appropriate use of these drugs aimed at maximizing their potential benefits and minimizing their risks."
FDA has asked Pfizer, Inc. to withdraw Bextra (valdecoxib) from the market because the overall risk versus benefit profile for the drug is unfavorable. FDA has also asked Pfizer to include a boxed warning in the Celebrex (celecoxib) label. Pfizer has agreed to suspend sales and marketing of Bextra in the U.S., pending further discussions with the agency. Pfizer has agreed to work with FDA on the boxed warning for Celebrex. FDA is asking manufacturers of all other prescription NSAIDs to revise their labels to include the same boxed warning highlighting the potential for increased risk of cardiovascular (CV) events and gastrointestinal (GI) bleeding associated with their use. Manufacturers of Celebrex and all other prescription NSAIDs will be asked to revise their labeling to include a Medication Guide for patients to help make them aware of the potential for CV and GI adverse events associated with the use of this class of drugs.
In addition, FDA is asking the manufacturers of all OTC NSAIDs to revise their labels to include more specific information about the potential CV and GI risks, and information to assist consumers in the safe use of the drugs. FDA is also asking manufacturers of OTC NSAIDs to include a warning about potential skin reactions. The labeling of the prescription NSAIDs already addresses potential skin reactions.
This current reexamination of the CV risks of NSAIDs began after Merck conducted a voluntary worldwide withdrawal of its COX-2 selective NSAID, Vioxx (rofecoxib), in September 2004. FDA will carefully review any proposal from Merck for resumption of marketing of Vioxx.
These actions are based on the available scientific data, including data accumulated since the drugs were approved. The FDA has carefully considered the presentations, discussions, and recommendations from the joint meeting of the Agency's Arthritis and Drug Safety and Risk Management Advisory Committee held on February 16-18, 2005.
To inform the public and healthcare community of its decisions, FDA today issued a Public Health Advisory (PHA) and updated patient and healthcare practitioner fact sheets.
Additional information about today's announcements is available on FDA's Web site at http://www.fda.gov/cder/index.html. Information can also be obtained by calling 1-888-INFO-FDA (888-463-6332).
####
最后编辑于 2022-10-09 · 浏览 792
1 1 点赞
