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【drug-news】FDA要求对避孕药添加新的警告内容
New Warning Added to Contraceptive Label
Friday January 18, 5:06 pm ET
New Precaution Added to Contraceptive Label
WASHINGTON (AP) -- A new study showing an increased risk of blood clots among women using a contraceptive skin patch prompted the Food and Drug Administration on Friday to add that finding to the drug's label.
The agency said the label on the Ortho Evra Contraceptive Transdermal Patch will include the results of a study in women aged 15-to-44 indicating a higher risk of clots than for women using birth control pills.
The blood clots could potentially lead to a lung embolism, the agency said.
"For women that choose to use contraceptives, it is important that they thoroughly discuss with their health care providers the risks and benefits involved," said Dr. Janet Woodcock, the FDA's deputy commissioner for scientific and medical programs.
The agency said it believes the patch is a safe and effective method of contraception, but recommends that women with concerns or risk factors for serious blood clots talk with their health care provider about contraceptive options.
The possibility of blood clots was first placed on the Ortho Evra label in September 2006.
Ortho Evra is a prescription patch that releases hormones through the skin into the blood stream. Because the hormones are processed by the body differently than hormones from birth control pills, women using the product will be exposed to about 60 percent more estrogen than if they were using typical birth control pills, FDA said.
Ortho-McNeil Pharmaceutical Inc. is a subsidiary of Johnson & Johnson. 本人已认领该文编译，48小时后若未提交译文，请其他战友自由认领 New Warning Added to Contraceptive Label
Friday January 18, 5:06 pm ET
New Precaution Added to Contraceptive Label
避孕药标签添加新告诫事项
1月18号，星期五，美国东部时间下午5:06
避孕药标签添加新警示
WASHINGTON (AP) -- A new study showing an increased risk of blood clots among women using a contraceptive skin patch prompted the Food and Drug Administration on Friday to add that finding to the drug's label.
华盛顿（AP）：最新的一项研究表明，使用避孕透皮贴剂的女性患血栓疾病的危险性增加，这一研究促使食品与药品管理局（FDA）在该贴剂的标签上增加该研究结果
The agency said the label on the Ortho Evra Contraceptive Transdermal Patch will include the results of a study in women aged 15-to-44 indicating a higher risk of clots than for women using birth control pills.
FDA声称，女用避孕透皮贴剂上的标签内容将增加一项新的研究结果，该研究表明在15-44岁的女性当中，使用透皮贴剂的女性比服用避孕药丸的女性发生血栓的风险要高。
The blood clots could potentially lead to a lung embolism, the agency said.
该机构认为“血栓会增加肺栓塞的几率”，
"For women that choose to use contraceptives, it is important that they thoroughly discuss with their health care providers the risks and benefits involved," said Dr. Janet Woodcock, the FDA's deputy commissioner for scientific and medical programs.
“对于使用避孕药的女性来说，与保健医生讨论服用避孕药所带来的风险和益处是十分重要的”，FDA科学和医学委员会的副会长珍妮特 伍德库克博士说
The agency said it believes the patch is a safe and effective method of contraception, but recommends that women with concerns or risk factors for serious blood clots talk with their health care provider about contraceptive options.
FDA同时声称，透皮贴剂是一种安全有效的避孕工具，但是如果女性对严重血栓疾病有顾虑或本身有罹患血栓的高危因素，应向其保健医生咨询避孕药的选择
The possibility of blood clots was first placed on the Ortho Evra label in September 2006.
2006年9月，Ortho Evra首次在其产品标签上标识其可能导致血栓
Ortho Evra is a prescription patch that releases hormones through the skin into the blood stream. Because the hormones are processed by the body differently than hormones from birth control pills, women using the product will be exposed to about 60 percent more estrogen than if they were using typical birth control pills, FDA said.
FDA表示，Ortho Evra是一种通过皮肤使激素释放入血的贴剂。由于人体产生的激素同避孕药所释放的激素有所不同，女性使用该贴剂要比服用常规避孕药受到高出60％多的雌激素作用。 编译如下：
华盛顿（AP）：最新的一项研究表明，使用避孕透皮贴剂的女性患血栓疾病的危险性增加，这一研究促使食品与药品管理局（FDA）在该贴剂的标签上增加了该研究结果的发现，以提醒消费者。FDA表示，女用避孕透皮贴剂上的标签内容将增加一项新的研究结果，该研究表明在15-44岁的女性当中，使用透皮贴剂的女性比服用避孕药丸的女性发生血栓的风险要高，且血栓会增加肺栓塞的机率。FDA同时又表示透皮贴剂是一种安全有效的避孕工具，但是如果女性对患严重血栓性疾病有顾虑或本身有罹患血栓的高危因素，则应向其保健医生咨询避孕药的选择。FDA科学和医学委员会的副会长珍妮特 伍德库克博士则认为“对于使用避孕药的女性，与保健医生讨论并了解服用避孕药所带来的风险和益处是十分必要的”。
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作者:admin@医学,生命科学 2011-04-18 17:14
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