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Medical Forum / Diseases and Disorders / Asthma / August 2003

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New Warnings Added to Glaxo Asthma Drugs  

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NorthShoreCEO - 14 Aug 2003 20:39 GMT
Just an FYI type of thing:

New Warnings Added to Glaxo Asthma Drugs  


Thursday August 14, 12:15 PM EDT

WASHINGTON (Reuters) - GlaxoSmithKline Plc's (GSK) asthma drugs Serevent and
Advair will carry new warnings about a small risk of life-threatening asthma
episodes or asthma-related deaths, the Food and Drug Administration said
Thursday.

The FDA, in a statement, said the benefits of treating patients with Serevent
or Advair continue to outweigh the risks when used according to instructions.

Both drugs contain an active ingredient called salmeterol, a long-acting beta
agonist that relaxes the bronchial muscles and allows patients to breathe more
easily.

Serevent was launched on the U.S. market in 1994, and the company started a
study of it in 1996 to address safety questions.

In January, GlaxoSmithKline announced it had halted the Serevent trial after
seeing more life-threatening asthma episodes, including deaths, in patients
treated with the drug rather than a placebo.

Patients should not stop taking either Advair or Serevent without consulting a
doctor because abruptly stopping it could lead to possibly life-threatening
disease flare-ups, the FDA said.

Officials at GlaxoSmithKline were not immediately available for comment.
CBI - 19 Aug 2003 03:44 GMT
> Just an FYI type of thing:
>
[quoted text clipped - 6 lines]
> episodes or asthma-related deaths, the Food and Drug Administration said
> Thursday.

I've been talking about this for years (search Google - I've said it here
several times). We figured out a long time ago that giving "standing" (i.e.
regularly scheduled) doses of albuterol three or four times a day was a bad
idea since it was associated with an increased risk of death. Serevent is
just a modified albuterol molecule that lasts twelve hours rather than six.
It is usually given twice daily pruducing the exact same constant receptor
stimulation as giving albuterol every six hours.  I have never understood
why anyone thought this would work out differently.

--
CBI, MD
 
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