邱宇鋒醫師(香港註冊中醫師),邱醫師畢業於香港浸會大學,多年從事醫管局管轄之中醫診所及醫院行醫,著有<<註冊中。醫師>>一書。

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嚴浩輝醫師(香港註冊中醫師),嚴醫師2005 年於香港大學中醫全科學士學位畢業。

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非處方藥[Alli愛纖伴]=[Orlistat奧利司他60mg]

服減肥藥要小心!
非處方藥[Alli愛纖伴]=[Orlistat奧利司他60mg]
小心損肝!

http://vtcm.xanga.com/727126772/beware-of-bodytriming-drugs/

各位師友:
今天am730 免費報首頁廣告非處方減肥新藥[Alli愛纖伴]原來是 [Orlistat奧利司他60mg],一隻
美國食品及藥物管理局(FDA)監察的藥, 一時手痒, 寫了一封投訴信給衛生署如下:
杏林之聲
嚴浩輝
2010.05.14
*************************************
enquiries@dh.gov.hk   
衛生署署長,
您好! 今天有報章刊出有關名為Alli(奧利司他60mg)的OTC藥物廣告(請看附件), 內容標榜其為美國FDA批准OTC藥物, 查美國FDA早於2007年批准該藥, 但2009年太陽報曾報導過FDA於該年將此藥列於觀察名單, 原因是美國FDA曾接獲三十二宗服食減肥藥奧利司他後引致肝臟嚴重受損的報導(請看以下文章).
想請問貴署是否有責任去將這些重要資訊通知消費者, 因為這些都是不用醫生處方便可購買的藥物, 對其廣告的監管比處方藥理應還要嚴, 現在這廣告藥名不顯眼, 也沒有警告, 如果有人減肥深切, 大量購買服食, 會否出事?
煩請解答
一市民上



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含奧利司他減肥藥損肝
http://the-sun.on.cc/cnt/news/20090826/00410_034.html


太陽報2009年08月26日新聞

含奧利司他減肥藥損肝【本報綜合報道】美國食品及藥物管理局(FDA)在九九年至去年,接獲三十二宗服食減肥藥奧利司他後引致肝臟嚴重受損的報告,其中二十七人須入院,六人更出現肝衰竭。該類藥物透過排油減肥,本港有售的賽尼可和沒有在港註冊的Alli都含奧利司他。生署表示,賽尼可九九年在港註冊,屬處方藥物,市民須憑醫生處方購買,該藥已附有會損害肝臟的警告字句。 FDA指出,服這類減肥藥有嚴重副作用的人,主要有疲倦、黃疸和胃痛病徵,但暫時無證據顯示,他們肝臟受損與服食這兩種減肥藥有直接關係,故服賽尼可的病人應繼續按照醫生處方服用,而服食Alli這種毋須醫生處方藥物的人士亦不需停服,只建議病人服用藥物後,出現疲倦、發燒、黃疸、小便呈棕色、腹痛、作嘔或食欲不振徵狀,便要求診。

香港醫院藥劑師學會副主席崔俊明指出,賽尼可是本港最常用的減肥藥,透過減少腸胃攝取食物中的油分三成,達到減肥目的,但病人有機會出現頭痛、大便帶油和腹瀉等副作用。由於以往未有報告顯示該類藥物會損害肝臟,故FDA仍要繼續收集更多資料進行分析,暫時不建議停服。


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Early Communication about an Ongoing Safety Review Orlistat (marketed as Alli and Xenical)

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm179166.htm

8/24/2009

FDA is reviewing new safe
ty information regarding reports of liver-related adverse events in patients taking orlistat. Orlistat is marketed in the United States as a prescription product, Xenical, and as an over-the-counter (OTC) product, Alli.

Xenical (orlistat 120mg) was approved as a prescription product by FDA in 1999 for obesity management in conjunction with a reduced caloric diet, and to reduce the risk of regaining weight after prior weight loss. In 2007, Alli (orlistat 60mg) was approved for OTC use for weight loss in overweight adults, 18 years and older, in conjunction with a reduced-calorie and low-fat diet. Currently, orlistat is approved for marketing in approximately 100 countries. In January 2009, a nonprescription version of orlistat was approved for sale in the European Union.

Between 1999 and October 2008, 32 reports of serious liver injury, including 6 cases of liver failure, in patients using orlistat were submitted to FDA’s Adverse Event Reporting System. Thirty of the 32 reports occurred outside the United States. The most commonly reported adverse events described in the 32 reports of serious liver injury were jaundice (yellowing of the skin or whites of the eyes), weakness, and abdominal pain. Hospitalization was reported in 27 of the 32 cases.

In addition to the 32 reported cases, this issue was discussed at the CDER Drug Safety Oversight Board in April 2009, and FDA is reviewing other data on suspected cases of liver injury submitted by the manufacturers of orlistat. FDA’s analysis of these data is ongoing and no definite association between liver injury and orlistat has been established at this time.

FDA is not advising healthcare professionals to change their prescribing practices with orlistat. Consumers currently taking Xenical should continue to take it as prescribed and those using over-the-counter Alli should continue to use the product as directed.

Consumers should consult their health care professional if they are experiencing symptoms possibly associated with the use of orlistat and development of liver injury, particularly weakness or fatigue, fever, jaundice or brown urine. Other symptoms may include abdominal pain, nausea, vomiting, light-colored stools, itching, or loss of appetite.

FDA urges both healthcare professionals and consumers to report side effects from the use of orlistat (Alli and Xenical) to FDA's MedWatch Adverse Event Reporting program using the information at the bottom of the page.

This early communication is in keeping with FDA’s commitment to inform the public about its ongoing safety reviews of drugs.  FDA will communicate its findings to the public as soon as its review of orlistat is complete.

This information reflects FDA’s current analysis of available data concerning these drugs. Posting this information does not mean that FDA has concluded there is a causal relationship between the drug products and the emerging safety issue. Nor does it mean that FDA is advising health care professionals to discontinue prescribing these products. FDA is considering, but has not reached a conclusion about whether this information warrants any regulatory action. FDA intends to update this document when additional information or analyses become available

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Orlistat (marketed as Alli and Xenical): Early Communication about an Ongoing Safety Review


http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm180025.htm

Audience: Endocrinological healthcare professionals, patients
FDA notified healthcare professionals and patients that it is reviewing new safety information regarding reports of liver-related adverse events in patients taking orlistat. Orlistat is marketed in the United States as a prescription product, Xenical, and as an over-the-counter (OTC) product, Alli. Between 1999 and October 2008, 32 reports of serious liver injury, including 6 cases of liver failure, in patients using orlistat were submitted to


FDA’s Adverse Event Reporting System. The most commonly reported adverse events described in the 32 reports of serious liver injury were jaundice, weakness, and abdominal pain. FDA is reviewing other data on suspected cases of liver injury submitted by the manufacturers of orlistat, analysis of these data is ongoing and no definite association between liver injury and orlistat has been established at this time. FDA is not advising healthcare professionals to change their prescribing practices with orlistat. Consumers currently taking Xenical should continue to take it as prescribed and those using over-the-counter Alli should continue to use the product as directed.

FDA urges both healthcare professionals and consumers to report side effects from the use of orlistat (Alli and Xenical) to FDA's MedWatch Adverse Event Reporting program1.

[08/24/2009 - Early Communication About an Ongoing Safety Review2 - FDA]

[08/24/2009 - News Release3 - FDA]



[ 本帖最後由 嚴醫師 於 2010-5-15 11:35 編輯 ]