Pharmaceutical News
Published: Thursday, 3-May-2007
The Food and Drug Administration (FDA) in the United States wants the manufacturers of antidepressant medications to change the labels on their products.
The FDA says all antidepressants should carry new warnings about an increased risk of suicidal thoughts and behavior in young adults ages 18 to 24 during the first few months of treatment.
The proposal will mean current black box warnings on the drugs will be updated to include language stating that scientific data did not show this increased risk in adults older than 24, and that adults ages 65 and older taking antidepressants have a decreased risk of suicidality.
The warning will also emphasize that depression and certain other serious psychiatric disorders are themselves the most important causes of suicide.
The FDA says studies have consistently shown a "slight increase" in suicidal thinking and behavior among young adults during early treatment, but the data did not find a higher risk for adults older than 24.
Dr. Steven Galson, director of the FDA's Center for Drug Evaluation and Research, says the proposed action represents the FDA's commitment to a high level of post-marketing evaluation of drug products.
Dr. Galson says depression and other psychiatric disorders can have significant consequences if not appropriately treated and antidepressant medications benefit many patients, but it is important that doctors and patients are aware of the risks.
Experts advise people currently prescribed antidepressant medications to continue taking them and see their doctor about any concerns they might have.
The proposed labeling changes apply to the entire category of antidepressants and follows similar labeling changes made in 2005 that warned of a suicidality risk in children and adolescents who use antidepressants.
At that time the FDA requested manufacturers add a black box warning to the labeling of all antidepressants to describe this risk and to emphasize the need for appropriate monitoring and close observation, particularly for younger patients taking these medications.
The FDA also directed manufacturers to develop FDA-approved Medication Guides, which gave user-friendly information to patients.
The Medication Guides are intended to be distributed at the pharmacy with each prescription or refill of a medication.
Following a comprehensive review in 2005 by the FDA of 295 individual antidepressant trials, in 2006, the FDA's Psychopharmacologic Drugs Advisory Committee agreed that labeling changes were needed.
The review included over 77,000 adult patients with major depressive disorder (MDD) and other psychiatric disorders, and examined the risk of suicidality in adults who are prescribed antidepressants.
The committee said that product labeling needed to reflect the apparent beneficial effect of antidepressants in older adults and to remind health care professionals that the disorders themselves are the most important cause of suicidality.
The FDA has given the manufacturers of antidepressants 30 days to submit their revised product labels and revised Medication Guides to the FDA for review.
Products involved include: Anafranil, Asendin, Aventyl, Celexa, Cymbalta, Desyrel, Elavil, Effexor, Emsam, Etrafon, fluvoxamine maleate, Lexapro, Limbitrol, Ludiomil, Marplan, Nardil, nefazodone HCl, Norpramin, Pamelor, Parnate, Paxil, Pexeva, Prozac, Remeron Sarafem, Seroquel, Sinequan, Surmontil, Symbyax, Tofranil, Tofranil-PM, Triavil, Vivactil, Wellbutrin, Zoloft and Zyban.
For more information go to www.fda.gov/cder/drug/antidepressants/default.htm
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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
The Food and Drug Administration (FDA) in the United States wants the manufacturers of antidepressant medications to change the labels on their products.The FDA says all antidepressants should carry new warnings about an increased risk of suicidal thoughts and behavior in young adults ages 18 to 24 during the first few months of treatment. 美国食品药品监督局要求抗抑郁治疗药物的制造商改变他们产品的标签。美国食品药品监督局认为所用的抗抑郁药应该加上在18-24岁的年轻人在开始治疗的几个月内又增加自杀想法和行为的警告标识。
The proposal will mean current black box warnings on the drugs will be updated to include language stating that scientific data did not show this increased risk in adults older than 24, and that adults ages 65 and older taking antidepressants have a decreased risk of suicidality.这个建议意味着现在抗抑郁药的黑色盒子警告需要更新，需要用语言叙述在24-65的成年人不增加自杀的风险，同时对65以上的老年人有降低自杀的风险。
The warning will also emphasize that depression and certain other serious psychiatric disorders are themselves the most important causes of suicide.这个警告也强调抑郁和其他的严重的精神疾病是自杀的重要原因。
The FDA says studies have consistently shown a "slight increase" in suicidal thinking and behavior among young adults during early treatment, but the data did not find a higher risk for adults older than 24. 食品药品监督局说研究显示在年轻的成年人中在早期的治疗过程中，自杀倾向有轻微的升高，但是对于24岁以上的成年人未发现有自杀倾向升高。
Dr. Steven Galson, director of the FDA's Center for Drug Evaluation and Research, says the proposed action represents the FDA's commitment to a high level of post-marketing evaluation of drug products. 食品药品监督局药物评估研究中心的Dr. Steven Galson说,这个提议法案证明食品药品监督局对于药品的后期市场运作的高水平评估尽到了义务。
Dr. Galson says depression and other psychiatric disorders can have significant consequences if not appropriately treated and antidepressant medications benefit many patients, but it is important that doctors and patients are aware of the risks. Dr. Galson说不经过正确的治疗，没有抗抑郁药的作用，抑郁和其他的精神疾病导致严重的后果，对于医生和患者知道这一点很重要。
Experts advise people currently prescribed antidepressant medications to continue taking them and see their doctor about any concerns they might have.专家建议在人们购买和服用抗抑郁药的过程中，如果任何疑问都应该去看医生。
The proposed labeling changes apply to the entire category of antidepressants and follows similar labeling changes made in 2005 that warned of a suicidality risk in children and adolescents who use antidepressants.继2005年抗抑郁药的标签警告关于儿童和青少年服用的自杀风险问题修改后，与上次提案相似，本提案修改会在整类抗抑郁药品中展开。
At that time the FDA requested manufacturers add a black box warning to the labeling of all antidepressants to describe this risk and to emphasize the need for appropriate monitoring and close observation, particularly for younger patients taking these medications. 同时食品药品监督局需要制造商在黑色的盒子里面加一个说明，描述服用药物的风险和强调需要正确的监测和观察，特别是对于那些服用药物的年轻患者。
The FDA also directed manufacturers to develop FDA-approved Medication Guides, which gave user-friendly information to patients. 食品药品监督局也会指导制造制作一个食品药品监督局认可的药物说明书，使说明书能给患者提供友好的信息。
The Medication Guides are intended to be distributed at the pharmacy with each prescription or refill of a medication. 药物说明书需要分配给药房中每一个开药和发药的人。
Following a comprehensive review in 2005 by the FDA of 295 individual antidepressant trials, in 2006, the FDA's Psychopharmacologic Drugs Advisory Committee agreed that labeling changes were needed.在2005年食品药品监督局观察了295个服用抗抑郁药的病例，并做了综述，食品药品监督局心理学药物咨询委员会认为标签更换是必要的。
The review included over 77,000 adult patients with major depressive disorder (MDD) and other psychiatric disorders, and examined the risk of suicidality in adults who are prescribed antidepressants. 综述包括77000以上的成年重郁症和其他精神疾病患者服药后他们的自杀风险的检查。
The committee said that product labeling needed to reflect the apparent beneficial effect of antidepressants in older adults and to remind health care professionals that the disorders themselves are the most important cause of suicidality.务员会认为产品说明书需要反映抗抑郁药对于老年患者的明显益处，并且使卫生保健工作者清楚精神失调是自杀的最重要原因。
The FDA has given the manufacturers of antidepressants 30 days to submit their revised product labels and revised Medication Guides to the FDA for review. 食品药品监督局给制造商30天的时间去提交修改的产品标签和说明书。
Products involved include: Anafranil, Asendin, Aventyl, Celexa, Cymbalta, Desyrel, Elavil, Effexor, Emsam, Etrafon, fluvoxamine maleate, Lexapro, Limbitrol, Ludiomil, Marplan, Nardil, nefazodone HCl, Norpramin, Pamelor, Parnate, Paxil, Pexeva, Prozac, Remeron Sarafem, Seroquel, Sinequan, Surmontil, Symbyax, Tofranil, Tofranil-PM, Triavil, Vivactil, Wellbutrin, Zoloft and Zyban.
产品包括Anafranil, Asendin, Aventyl, Celexa, Cymbalta, Desyrel, Elavil, Effexor, Emsam, Etrafon, fluvoxamine maleate, Lexapro, Limbitrol, Ludiomil, Marplan, Nardil, nefazodone HCl, Norpramin, Pamelor, Parnate, Paxil, Pexeva, Prozac, Remeron Sarafem, Seroquel, Sinequan, Surmontil, Symbyax, Tofranil, Tofranil-PM, Triavil, Vivactil, Wellbutrin, Zoloft and Zyban.
美国食品药品监督局要求抗抑郁治疗药物的制造商改变他们产品的标签。美国食品药品监督局认为所用的抗抑郁药应该加上在18-24岁的年轻人在开始治疗的几个月内有增加自杀想法和行为的警告标识。这个建议意味着现在抗抑郁药的黑色盒子警告需要更新，需要用语言叙述在24-65的成年人不增加自杀的风险，同时对65以上的老年人有降低自杀的风险。这个警告也强调抑郁和其他的严重的精神疾病是自杀的重要原因。食品药品监督局说研究显示在年轻的成年人中在早期的治疗过程中，自杀倾向有轻微的升高，但是对于24岁以上的成年人未发现有自杀倾向升高。食品药品监督局药物评估研究中心的Dr. Steven Galson说,这个提议法案证明食品药品监督局对于药品的后期市场运作的高水平评估尽到了义务。Dr. Galson说不经过正确的治疗，没有抗抑郁药的作用，抑郁和其他的精神疾病会导致严重的后果，对于医生和患者知道这一点很重要。专家建议在人们购买和服用抗抑郁药的过程中，如果任何疑问都应该去看医生。继2005年抗抑郁药的标签警告关于儿童和青少年服用的自杀风险问题修改后，与上次提案相似，本提案修改会在整类抗抑郁药品中展开。同时食品药品监督局需要制造商在黑色的盒子里面加一个说明，描述服用药物的风险和强调需要正确的监测和观察，特别是对于那些服用药物的年轻患者。食品药品监督局也会指导制造制作一个食品药品监督局认可的药物说明书，使说明书能给患者提供友好的信息。药物说明书需要分配给药房中每一个开药和发药的人。在2005年食品药品监督局观察了295个服用抗抑郁药的病例，并做了综述，食品药品监督局心理学药物咨询委员会认为标签更换是必要的。综述包括77000以上的成年重郁症和其他精神疾病患者服药后他们的自杀风险的检查。委员会认为产品说明书需要反映抗抑郁药对于老年患者的明显益处，并且使卫生保健工作者清楚精神失调是自杀的最重要原因。食品药品监督局给制造商30天的时间去提交修改的产品标签和说明书。产品包括Anafranil, Asendin, Aventyl, Celexa, Cymbalta, Desyrel, Elavil, Effexor, Emsam, Etrafon, fluvoxamine maleate, Lexapro, Limbitrol, Ludiomil, Marplan, Nardil, nefazodone HCl, Norpramin, Pamelor, Parnate, Paxil, Pexeva, Prozac, Remeron Sarafem, Seroquel, Sinequan, Surmontil, Symbyax, Tofranil, Tofranil-PM, Triavil, Vivactil, Wellbutrin, Zoloft and Zyban.
拙见：
1The FDA says all antidepressants should carry new warnings about an increased risk of suicidal thoughts and behavior in young adults ages 18 to 24 during the first few months of treatment.美国食品药品监督局认为所用的抗抑郁药应该加上在18-24岁的年轻人在开始治疗的几个月内又增加自杀想法和行为的警告标识。
－－美国食品药品监督局认为所有抗抑郁药物需加上新的警告标识，以提示18-24岁的年轻人在开始治疗的几个月内会出现自杀想法和行为增多的危险。
2.The proposal will mean current black box warnings on the drugs will be updated to include language stating that scientific data did not show this increased risk in adults older than 24, and that adults ages 65 and older taking antidepressants have a decreased risk of suicidality.这个建议意味着现在抗抑郁药的黑色盒子警告需要更新，需要用语言叙述在24-65的成年人不增加自杀的风险，同时对65以上的老年人有降低自杀的风险。
－－这个建议意味着现在抗抑郁药的黑色盒子警告标签需要更新，包括说明在24-65的成年人不增加自杀的风险，同时对65以上的老年人有降低自杀风险的字语。
3The warning will also emphasize that depression and certain other serious psychiatric disorders are themselves the most important causes of suicide.这个警告也强调抑郁和其他的严重的精神疾病是自杀的重要原因。
－－这个警告也强调了抑郁症和其他某些严重的精神疾病本身就是自杀的最重要原因。
4The FDA says studies have consistently shown a "slight increase" in suicidal thinking and behavior among young adults during early treatment, but the data did not find a higher risk for adults older than 24. 食品药品监督局说研究显示在年轻的成年人中在早期的治疗过程中，自杀倾向有轻微的升高，但是对于24岁以上的成年人未发现有自杀倾向升高。
－－食品药品监督局说研究一致显示年轻的成年人在早期治疗中会出现自杀倾向的轻微升高，但数据未发现24岁以上的成年人会出现这危险。
谢谢fanaiwen战友的润色，比我的初始翻译要通顺、易懂！
但没有本质变化！希望大家能发现错误之处并指正，以求共同进步！
个人愚见，仅供参考：
1. Dr. Steven Galson, director of the FDA's Center for Drug Evaluation and Research, says the proposed action represents the FDA's commitment to a high level of post-marketing evaluation of drug products. 食品药品监督局药物评估研究中心的Dr. Steven Galson说,这个提议法案证明食品药品监督局对于药品的后期市场运作的高水平评估尽到了义务。
FDA药物评价研究中心主任Steven Galson博士称，该提议体现了FDA对上市药品高水平的评价。
2. Dr. Galson says depression and other psychiatric disorders can have significant consequences if not appropriately treated and antidepressant medications benefit many patients, but it is important that doctors and patients are aware of the risks. Dr. Galson说不经过正确的治疗，没有抗抑郁药的作用，抑郁和其他的精神疾病导致严重的后果，对于医生和患者知道这一点很重要。
Dr. Galson说如果治疗不当，抑郁和其他的精神疾病会导致严重的后果；抗抑郁药可使许多患者受益，但医生和患者知道（用药）风险是很重要的。
3. Experts advise people currently prescribed antidepressant medications to continue taking them and see their doctor about any concerns they might have.专家建议在人们购买和服用抗抑郁药的过程中，如果任何疑问都应该去看医生。
专家建议，目前正在服用抗抑郁药的患者可继续用药，如果有任何疑问可咨询他们的医生。
4. At that time the FDA requested manufacturers add a black box warning to the labeling of all antidepressants to .... 同时食品药品监督局需要制造商在黑色的盒子里面加一个说明，...
那次，FDA要求制造商在所有抗抑郁药标签上增加一个黑框警告，...
5. The Medication Guides are intended to be distributed at the pharmacy with each prescription or refill of a medication. 药物说明书需要分配给药房中每一个开药和发药的人。
药物指南应在药房中随每张处方发放或添加到每一药盒中。
6. Following a comprehensive review in 2005 by the FDA of 295 individual antidepressant trials, in 2006, the FDA's Psychopharmacologic Drugs Advisory Committee agreed that labeling changes were needed.在2005年食品药品监督局观察了295个服用抗抑郁药的病例，并做了综述，食品药品监督局心理学药物咨询委员会认为标签更换是必要的。
FDA在2005年全面审查了295个独立的抗抑郁药临床试验结果后，2006年FDA精神药物咨询委员会认为标签更换是必要的。
谢谢发帖的考虑的很周到，不过本人觉得没有必要翻译过来，这样对有兴趣的人来说可以锻炼自己的外文水平，很好地机会，很好地挑战．翻译了到有些多此一举．
wakin2009 wrote:
谢谢发帖的考虑的很周到，不过本人觉得没有必要翻译过来，这样对有兴趣的人来说可以锻炼自己的外文水平，很好地机会，很好地挑战．翻译了到有些多此一举．
4. At that time the FDA requested manufacturers add a black box warning to the labeling of all antidepressants to .... 同时食品药品监督局需要制造商在黑色的盒子里面加一个说明，...
那次，FDA要求制造商在所有抗抑郁药标签上增加一个黑框警告，...
5. The Medication Guides are intended to be distributed at the pharmacy with each prescription or refill of a medication. 药物说明书需要分配给药房中每一个开药和发药的人。
药物指南应在药房中随每张处方发放或添加到每一药盒中。
翻译过来，经高手点评后可以提高我们的英语水平，感谢高手指导！
