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【drug-news】FDA发布安眠药物警告

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http://www.nytimes.com/2007/03/15/business/14sleep.web.html?ref=business
F.D.A. Issues Warning on Sleeping Pills
J.B. Reed/Bloomberg News

Published: March 15, 2007
Prescription sleeping pills can cause unusual behavior like driving and eating while asleep, the Food and Drug Administration warned today.

Skip to next paragraph
Release From the F.D.A.
Back Story With The Times's Stephanie Saul (mp3)
Related
Some Sleeping Pill Users Range Far Beyond Bed (March 8, 2006)
Study Links Ambien Use to Unconscious Food Forays (March 14, 2006) The F.D.A. ordered the makers of Ambien, Lunesta and 11 other commonly used sleep medications to issue strong new label warnings about those risks, and to produce brochures about safe use of the drugs. Pharmacies would give the brochures to patients when prescriptions are dispensed.

The agency will also require label warnings to note the possibility of severe allergic reactions and facial swelling associated with the use of such sleep medications.

The agency had been reviewing the side effects of sleeping pills since last year, after some users of the widely prescribed drug Ambien complained that they sleepwalked and gorged themselves on food or were arrested while driving in their sleep.

In each case the consumers had no recollection of the events, which occurred after they took Ambien and headed for bed.

The agency said that it had reviewed its database of reports of problems with the 13 commonly used sleep medications and concluded that labeling changes were needed. In a news release today, the F.D.A. warned patients of the potential for “complex sleep-related behaviors” which may include “sleep-driving, making phone calls and preparing and eating food (while asleep).”

The release defined “sleep driving” as “driving while not fully awake after ingestion of a sedative hypnotic, with no memory of the event.”

The F.D.A. also said it was taking the added step of asking manufacturers to conduct additional clinical studies involving sleep driving and other complex behaviors associated with taking the medications.

Besides Ambien and Lunesta, the drugs include Sonata and Rozerem, and a number of older medications.

The F.D.A.’s move follows a warning last month by authorities in Australia, where Ambien is marketed as Stilnox. The Australian drug agency said it had uncovered a variety of unusual activities by consumers using the product, including sleep-driving, sleep-eating, and, in one case, a woman who painted the front door of her home while asleep.

Here are the 13 sleep drugs, and their makers, as listed by the F.D.A.:

•

Ambien/AmbienCR (Sanofi-Aventis)

•

Butisol Sodium (MedPointe Pharmaceuticals)

•

Carbrital (Parke-Davis)

•

Dalmane (Valeant Pharmaceuticals)

•

Doral (Questcor Pharmaceuticals)

•

Halcion (Pharmacia & Upjohn)

•

Lunesta (Sepracor)

•

Placidyl (Abbott)

•

ProSom (Abbott)

•

Restoril (Tyco Healthcare)

•

Rozerem (Takeda)

•

Seconal (Eli Lilly)

•

Sonata (King Pharmaceuticals)

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2007-03-15 07:58 浏览 : 952 回复 : 3

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ivan928

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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。

2007-03-15 08:33

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FDA News
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01587.html
官方报道
FOR IMMEDIATE RELEASE
P07-45
March 14, 2007
Media Inquiries:
Sandy Walsh
Kimberly Rawlings
301-827-6242
Consumer Inquiries:
888-INFO-FDA

FDA Requests Label Change for All Sleep Disorder Drug Products
The U.S. Food and Drug Administration (FDA) has requested that all manufacturers of sedative-hypnotic drug products, a class of drugs used to induce and/or maintain sleep, strengthen their product labeling to include stronger language concerning potential risks. These risks include severe allergic reactions and complex sleep-related behaviors, which may include sleep-driving. Sleep driving is defined as driving while not fully awake after ingestion of a sedative-hypnotic product, with no memory of the event.

"There are a number of prescription sleep aids available that are well-tolerated and effective for many people," said Steven Galson, M.D., MPH, director of FDA’s Center for Drug Evaluation and Research. "However, after reviewing the available post-marketing adverse event information for these products, FDA concluded that labeling changes are necessary to inform health care providers and consumers about risks."

In December 2006, FDA sent letters to manufacturers of products approved for the treatment of sleep disorders requesting that the whole class of drugs revise product labeling to include warnings about the following potential adverse events:

Anaphylaxis (severe allergic reaction) and angioedema (severe facial swelling), which can occur as early as the first time the product is taken.
Complex sleep-related behaviors which may include sleep-driving, making phone calls, and preparing and eating food (while asleep).
FDA has been working with the product manufacturers over the past three months to update labeling, notify health care providers and inform consumers of these risks.

Along with the labeling revisions, FDA has requested that each product manufacturer send letters to health care providers to notify them about the new warnings. Manufacturers will begin sending these letters to providers starting this week.

In addition, FDA has requested that manufacturers of sedative-hypnotic products develop Patient Medication Guides for the products to inform consumers about risks and advise them of potential precautions that can be taken. Patient Medication Guides are handouts given to patients, families and caregivers when a medicine is dispensed. The guides will contain FDA-approved information such as proper use and the recommendation to avoid ingesting alcohol and/or other central nervous system depressants. When these Medication Guides are available, patients being treated with sleep medications should read the information before taking the product and talk to their doctors if they have questions or concerns. Patients should not discontinue the use of these medications without first consulting their health care provider.

Although all sedative-hypnotic products have these risks, there may be differences among products in how often they occur. For this reason, FDA has recommended that the drug manufacturers conduct clinical studies to investigate the frequency with which sleep-driving and other complex behaviors occur in association with individual drug products.

The medications that are the focus of the revised labeling include the following 13 products:

Ambien/Ambien CR (Sanofi Aventis)
Butisol Sodium (Medpointe Pharm HLC)
Carbrital (Parke-Davis)
Dalmane (Valeant Pharm)
Doral (Questcor Pharms)
Halcion (Pharmacia & Upjohn)
Lunesta (Sepracor)
Placidyl (Abbott)
Prosom (Abbott)
Restoril (Tyco Healthcare)
Rozerem (Takeda)
Seconal (Lilly)
Sonata (King Pharmaceuticals)

For more information on the sedative hypnotic products and sleep disorders, visit http://www.fda.gov/cder/drug/infopage/sedative_hypnotics/default.htm;
www.fda.gov/womens/getthefacts/sleep.html and www.nhlbi.nih.gov/health/dci/Diseases/inso/inso_whatis.html.

2007-03-16 12:46

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FDA Requests Label Change for All Sleep Disorder Drug Products
FDA要求所有的睡眠障碍药物制造商更换药物标签
The U.S. Food and Drug Administration (FDA) has requested that all manufacturers of sedative-hypnotic drug products, a class of drugs used to induce and/or maintain sleep, strengthen their product labeling to include stronger language concerning potential risks. These risks include severe allergic reactions and complex sleep-related behaviors, which may include sleep-driving. Sleep driving is defined as driving while not fully awake after ingestion of a sedative-hypnotic product, with no memory of the event.
FDA要求所有的生产用于催眠或保持睡眠的镇静-安眠药物的制造商，都必须强化他们的产品标签内容，并使用严厉的语气写出有关的潜在风险。这些风险包括重度变态反应和复杂的睡眠相关行为，这可能包括睡眠驾驶。睡眠驾驶的定义是指服用镇静-安眠药物后没有完全觉醒的驾驶行为，并且醒来后对此事没有记忆。
"There are a number of prescription sleep aids available that are well-tolerated and effective for many people," said Steven Galson, M.D., MPH, director of FDA’s Center for Drug Evaluation and Research. "However, after reviewing the available post-marketing adverse event information for these products, FDA concluded that labeling changes are necessary to inform health care providers and consumers about risks."
FDA的药品评价与研究中心的主管，Steven Galson博士说：“有很多处方睡眠辅助药都有很好的耐受性，对很多人效果也不错。但是，我们得到了一些关于这些药物市场销售后的使用不良反应，FDA认为必须更换药品标签，使那些保健提供者和消费者清楚用药风险。
In December 2006, FDA sent letters to manufacturers of products approved for the treatment of sleep disorders requesting that the whole class of drugs revise product labeling to include warnings about the following potential adverse events:
在2006年12月，FDA就写信给那些生产用于治疗睡眠障碍的药物制造商，让他们修订下面药物的产品标签，包括对下列潜在的不良反应提出警告：
Anaphylaxis (severe allergic reaction) and angioedema (severe facial swelling), which can occur as early as the first time the product is taken.
过敏反应（重度变应性反应）和血管性水肿（重度面部浮肿），这些症状在第一次服药是就可能出现。
Complex sleep-related behaviors which may include sleep-driving, making phone calls, and preparing and eating food (while asleep).
复杂的睡眠相关行为，包括睡眠驾驶，打电话和在睡梦中做饭、进食。
FDA has been working with the product manufacturers over the past three months to update labeling, notify health care providers and inform consumers of these risks.
FDA在过去的3个月内和药品制造商一起在修正产品标签，并告知保健提供者和消费者这些用药风险。
Along with the labeling revisions, FDA has requested that each product manufacturer send letters to health care providers to notify them about the new warnings. Manufacturers will begin sending these letters to providers starting this week.
修正产品标签的同时，FDA还要求每家制造商在这周就要提醒那些保健提供者注意新的使用警告。
In addition, FDA has requested that manufacturers of sedative-hypnotic products develop Patient Medication Guides for the products to inform consumers about risks and advise them of potential precautions that can be taken. Patient Medication Guides are handouts given to patients, families and caregivers when a medicine is dispensed. The guides will contain FDA-approved information such as proper use and the recommendation to avoid ingesting alcohol and/or other central nervous system depressants. When these Medication Guides are available, patients being treated with sleep medications should read the information before taking the product and talk to their doctors if they have questions or concerns. Patients should not discontinue the use of these medications without first consulting their health care provider.
FDA还要求这些镇静-安眠药物制造商为他们的药品制定患者用药指南，这样可以将用药风险告诉消费者，并指出服药的注意事项。向患者、家属和护理人员发放患者用药指南，指南必须包含FDA批准的信息，如正确使用，避免喝酒和（或）其它的中枢神经抑制剂。当有用药指南的患者使用安眠药时，他们可以先阅读这些内容，如果有问题或担忧时就可以向医生询问。在患者没有咨询过保健提供者时，不应该终止使用这些药物。
Although all sedative-hypnotic products have these risks, there may be differences among products in how often they occur. For this reason, FDA has recommended that the drug manufacturers conduct clinical studies to investigate the frequency with which sleep-driving and other complex behaviors occur in association with individual drug products.
尽管所有的镇静-安眠药物都有这些使用风险，但它们的发作频率还是不尽相同。所以FDA要求药品制造商进行临床研究，搞清楚睡眠驾驶和其它复杂行为出现的频率与个别药品的关系。
The medications that are the focus of the revised labeling include the following 13 products:
下面是13个受到关注的修正产品标签的药物
Ambien/Ambien CR (Sanofi Aventis)
使蒂诺斯（赛诺菲-安万特）
Butisol Sodium (Medpointe Pharm HLC)
布的索钠（Medpointe）
Carbrital (Parke-Davis)
戊巴比妥钠（帕克戴维）
Dalmane (Valeant Pharm)
盐酸氟西泮（瓦利安特）
Doral (Questcor Pharms)
夸西泮（奎斯特柯）
Halcion (Pharmacia & Upjohn)
海乐神（法玛西亚－普强）
Lunesta (Sepracor)
左旋佐匹克隆（塞普拉科）
Placidyl (Abbott)
乙氯维诺（雅培）
Prosom (Abbott)
艾司唑仑片剂（雅培）
Restoril (Tyco Healthcare)
替马西泮胶囊（泰科医疗器材公司）
Rozerem (Takeda)
Rozerem（武田）
Seconal (Lilly)
速可眠（礼来）
Sonata (King Pharmaceuticals)
扎来普隆（国王制药）
～～～～～～～～～～～～～～～～～～～～～～～～～～～～～

编译后：

FDA要求所有的睡眠障碍药物制造商更换产品标签
FDA要求所有的镇静-安眠药物制造商强化他们的产品标签内容，并郑重指出有关的潜在风险。这些风险包括重度变态反应和复杂的睡眠相关行为，包括睡眠驾驶，睡眠驾驶的定义是指服用镇静-安眠药物后没有完全觉醒的驾驶行为，并且醒来后对此事毫无记忆。
FDA的药品评价与研究中心的主管，Steven Galson博士说：“很多处方睡眠辅助药都有良好的耐受性，效果也不错。但是，我们得到了一些关于这些药物市场销售后的使用不良反应，我们认为必须更换药品标签，使那些保健提供者和消费者清楚用药风险。
在2006年12月，FDA就通知那些生产用于治疗睡眠障碍的药物制造商，让他们修订药物的产品标签，包括对下列潜在的不良反应提出警告：
1，过敏反应（重度变应性反应）和血管性水肿（重度面部浮肿），这些症状在第一次服药时就可能出现。
2，复杂的睡眠相关行为，包括睡眠驾驶，打电话和在睡梦中做饭、进食。
FDA在过去的3个月内和药品制造商一起在修正产品标签，并告知保健提供者和消费者这些用药风险。同时，FDA还要求制造商在本周就要提醒那些保健提供者注意新的使用警告。
FDA还要求这些镇静-安眠药物制造商为药品编写用药指南，这样可以将用药风险告诉消费者，并指出服药的注意事项。同时向患者、家属和护理人员发放用药指南，指南必须包含FDA批准的信息，如正确使用，避免喝酒和（或）同时服用其它的中枢神经抑制剂。当患者使用安眠药时，他们可以先阅读用药指南，如果有问题或顾虑就可以向医生询问。但患者没有咨询过保健提供者时，不应该终止使用这些药物。
尽管所有的镇静-安眠药物都有这些使用风险，但它们的发作频率还是不尽相同。所以FDA要求药品制造商进行临床研究，搞清楚睡眠驾驶和其它复杂行为出现的频率与个别药品的关系。
下面是13个受到关注的修正产品标签的药物及它们的制造商
使蒂诺斯（赛诺菲-安万特）
布的索钠（Medpointe）
戊巴比妥钠（帕克戴维）
盐酸氟西泮（瓦利安特）
夸西泮（奎斯特柯）
海乐神（法玛西亚－普强）
左旋佐匹克隆（塞普拉科）
乙氯维诺（雅培）
艾司唑仑片剂（雅培）
替马西泮胶囊（泰科医疗器材公司）
Rozerem（武田）
速可眠（礼来）
扎来普隆（国王制药）

有战友知道上面英文的中文译发请指正谢谢:)

2007-03-16 18:00

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ivan928 编辑于 2007-03-16 18:11

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