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【medical-news】FDA approves first nonprescription sale of
• Now available as Xenical, the nonprescription dose will have the name "alli."
• Orlistat works by blocking absorption of about one-quarter of any fat consumed
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WASHINGTON (AP) -- Dieters got a new tool Wednesday to help them take off the extra pounds -- the first government-approved nonprescription diet pill.
The Food and Drug Administration said the fat-blocking weight-loss pill orlistat, which has been available by prescription, can be sold in a reduced-strength version over the counter.
The new version will be sold as "alli" by GlacoSmithKline PLC. Xenical, the prescription version, is made by Roche Holding AG.
The drug is intended for people 18 and older to use along with a reduced-calorie, low-fat diet and exercise.
Dr. Charles Ganley, FDA's director of nonprescription products, stressed that the drug is intended for use along with diet and exercise programs.
"Using this drug alone is unlikely to be beneficial," Ganley said at a telebriefing.
While some dietary supplements make weight-loss claims, Ganley said this is the first nonprescription drug approved by the agency for that purpose.
Ganley said in trials, for every five pounds people lost through diet and exercise, those using orlistat lost an additional two to three pounds.
When taken with meals, orlistat blocks the absorption of about one-quarter of any fat consumed. That fat -- about 150 to 200 calories worth -- is passed out of the body in stools, which can be loose as a result. About half of patients in trials experienced gastrointestinal side effects.
The agency recommended users take a multivitamin when using this drug.
The new drug would contain half the dose of Xenical prescription capsules. The price has not been set but is expected to run $1 to $2 a day, company officials said. The company estimated 5 million to 6 million Americans a year would buy the drug over the counter.
The Food and Drug Administration said the most common side effect of the product is a change in bowel habits including loose stool and some oily spotting. Eating a low-fat diet will reduce the likelihood of this side effect.
FDA said people who have had organ transplants should not take OTC orlistat because of possible drug interactions. In addition, anyone taking blood-thinning medicines or being treated for diabetes or thyroid disease should consult a physician before using orlistat, the agency said.
GSK Consumer Healthcare, which will market the pill, said it chose the name alli to indicate a partnership with consumers in their weight-loss efforts.
"We know that being overweight has many adverse consequences, including an increase in the risk of heart disease and type 2 diabetes," said Dr. Douglas Throckmorton, deputy director for the FDA's Center for Drug Evaluation and Research.
"OTC orlistat, along with diet and exercise, may aid overweight adults who seek to lose excess weight to improve their health," he said.
Copyright 2007 The Associated Press. All rights reserved.This material may not be published, broadcast, rewritten, or redistributed. 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 由于有事让与“暗涌”19830127翻译 初译
FDA approves over-the-counter sales of the fat-blocking diet pill orlistat
FDA批准减少脂肪摄入的减肥药片奥利斯特为OTC药物。
• Now available as Xenical, the nonprescription dose will have the name "alli."
现在名为赛尼可上市，其非处方剂量药名为“alli.”
• Orlistat works by blocking absorption of about one-quarter of any fat consumed
奥利斯特阻止四分之一的摄入的任何脂肪的吸收
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WASHINGTON (AP) -- Dieters got a new tool Wednesday to help them take off the extra pounds -- the first government-approved nonprescription diet pill.
华盛顿（AP）－减肥者在星期三又有一项新的手段来减去多于的重量了－政府批准的第一个用于减肥的非处方片剂
The Food and Drug Administration said the fat-blocking weight-loss pill orlistat, which has been available by prescription, can be sold in a reduced-strength version over the counter.
食品药品管理局说，阻止脂肪摄入的减肥药奥里斯特，曾经是处方药，现在以减少长度的形式作为非处方药。
The new version will be sold as "alli" by GlacoSmithKline PLC. Xenical, the prescription version, is made by Roche Holding AG.
GlacoSmithKline PLC以alli为名销售这种形式的药物。赛尼可，其处方形式由Roche旗下的AG生产。
The drug is intended for people 18 and older to use along with a reduced-calorie, low-fat diet and exercise.
药物适宜于18岁及以上年龄段的人使用，并辅以低热量，低脂肪饮食及一定的锻炼。
Dr. Charles Ganley, FDA's director of nonprescription products, stressed that the drug is intended for use along with diet and exercise programs.
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作者:admin@医学,生命科学 2011-03-04 01:29
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