葛蘭素史克、諾華哮喘藥得新的美國警告

葛蘭素史克、諾華哮喘藥得新的美國警告
Glaxo, Novartis Asthma Drugs to Get New U.S. Warnings
Friday, 19 February 2010 10:51
News - Latest News

Glaxo, Novartis Asthma Drugs to Get New U.S. Warnings
February 18, 2010, 03:10 PM EST
By Molly Peterson

Feb. 18 (Bloomberg) -- GlaxoSmithKline Plc’s Serevent and Novartis AG’s Foradil should never be used alone to treat asthma, U.S. regulators said, also urging studies of combination treatments.
2月18日（彭博） - 葛蘭素史克公司的沙美特羅和諾華公司的福莫特羅，永遠不應單獨用以治療哮喘，美國監管當局說，亦催促研究組合治療。
The companies must add warnings to the two drugs’ prescribing information and take additional steps to lower their use, the Food and Drug Administration said today in a statement. The decision follows a review of the safety of medicines from a class known as long-acting beta agonists used by 6 million Americans to breathe more easily.
兩公司必須加警告在兩種藥物的處方信息，並採取其它部驟來降低使用量，食品和藥物管理局今天在一份聲明說。這個決定是在審查藥品的安全後，由一類被稱為長效β激動劑，被600萬美國人為更容易呼吸而使用。
The new prescribing information will warn that the drugs shouldn’t be used “without the use of an asthma controller medication such as inhaled corticosteroid.” Glaxo’s Advair and AstraZeneca Plc’s Symbicort combine the long-acting beta agonists and corticosteroids. The FDA will require manufacturers to conduct additional studies to evaluate the safety of the beta agonists when used with the inhaled corticosteroids.

Long-acting beta agonists “play an important role in helping some patients control asthma symptoms,” said Badrul Chowdhury, director of the Division of Pulmonary and Allergy Products in the FDA’s Center for Drug Evaluation and Research, said in the statement. Still, clinical data show that use of the products alone was linked to “an increased risk of asthma exacerbations, hospitalizations and death.”

The FDA has been concerned about the safety of the long- acting beta agonists for more than a decade, and the products carry the agency’s strongest caution about the risk of death.

--Editors: Robert Greene, Bruce Rule

To contact the reporter on this story: Molly Peterson in Washington at +1-202-624-1867 or mpeterson9@bloomberg.net This e-mail address is being protected from spambots. You need JavaScript enabled to view it

To contact the editor responsible for this story: Reg Gale at 212-617-2563 or rgale5@bloomberg.net This e-mail address is being protected from spambots. You need JavaScript enabled to view it .

http://www.theflucase.com/index.php?option=com_content&view=article&id=2781%3Aglaxo-novartis-asthma-drugs-to-get-new-us-warnings-&catid=1%3Alatest-news&Itemid=64&lang=en

美報告建議「安糖健」下架
(明報)2010年2月20日 星期六 14:50
美國食品及藥物管理局一份機密報告指，治糖尿病藥「安糖健」(Avandia)會傷害心臟，建議從市場上下架。

美國《紐約時報》引述美國食品及藥物管理局一份機密報告報道，葛蘭素史克(Glaxo Smith Kline)的治糖尿病藥「安糖健」(Avandia)會傷害心臟，建議從市場上下架。

報道指，如果美國現在使用「安糖健」的糖尿病患者，改用其他藥物，估計每個月可以減少500宗心臟病和300宗心臟衰竭的病例。

「安糖健」曾是葛蘭素史克藥廠排名第二的暢銷藥品，兩年前，美國發表它可能增加心臟病發機率的研究報告之後，銷量大減。

2007年，美國食品及藥物管理局以八票對七票通過諮詢委員會的建議，指即使「安糖健」可能有提高心臟病發的機率，但是應該還不到必須強制下架的程度。

（紐約時報）
http://hk.news.yahoo.com/article/100220/4/gnmf.html