Safety of another drug questioned.

Glaxo asthma drug needs kid risk warning-FDA panel
By Kim Dixon Thursday, November 29, 2007; 4:27 AM


GAITHERSBURG, Md. (Reuters) - U.S. regulatory advisers on Wednesday
recommended strengthening safety warnings on GlaxoSmithKline Plc's
asthma drug Serevent amid new reports of deaths in children taking the
drug.......

.........The data is very troubling because both the increase in
hospitalization and in mortality is so different" from what doctors
currently believe, said Thomas Newman, an epidemiologist at the
University of California, San Francisco, and panel member........

........At least two panel members said the data was so convincing that
Serevent should be pulled from the market. The FDA said it will
consider the safety of all drugs in the class, called long-acting beta
agonists, at a future meeting.... http://www.healthcentral.com/allergy...196410-66.html

Will the FDA move on this drug . Probably not.

Thanks Vince

bigvince wrote:
Glaxo asthma drug needs kid risk warning-FDA panel
By Kim Dixon Thursday, November 29, 2007; 4:27 AM


GAITHERSBURG, Md. (Reuters) - U.S. regulatory advisers on Wednesday
recommended strengthening safety warnings on GlaxoSmithKline Plc's
asthma drug Serevent amid new reports of deaths in children taking the
drug.......

........The data is very troubling because both the increase in
hospitalization and in mortality is so different" from what doctors
currently believe, said Thomas Newman, an epidemiologist at the
University of California, San Francisco, and panel member........

.......At least two panel members said the data was so convincing that
Serevent should be pulled from the market. The FDA said it will
consider the safety of all drugs in the class, called long-acting beta
agonists, at a future meeting.... http://www.healthcentral.com/allergy...196410-66.html

Will the FDA move on this drug . Probably not.

Thanks Vince

You're welcome.

Notice how conventional medicine gathers information and gets better as
new information comes in.

When's the last time you saw alternative medicine say something might
not be safe?

Jeff

On Nov 30, 9:34 am, Jeff wrote:
bigvince wrote:
Glaxo asthma drug needs kid risk warning-FDA panel
By Kim Dixon Thursday, November 29, 2007; 4:27 AM

GAITHERSBURG, Md. (Reuters) - U.S. regulatory advisers on Wednesday
recommended strengthening safety warnings on GlaxoSmithKline Plc's
asthma drug Serevent amid new reports of deaths in children taking the
drug.......

........The data is very troubling because both the increase in
hospitalization and in mortality is so different" from what doctors
currently believe, said Thomas Newman, an epidemiologist at the
University of California, San Francisco, and panel member........

.......At least two panel members said the data was so convincing that
Serevent should be pulled from the market. The FDA said it will
consider the safety of all drugs in the class, called long-acting beta
agonists, at a future meeting.... http://www.healthcentral.com/allergy...196410-66.html

Will the FDA move on this drug . Probably not.

Thanks Vince

You're welcome.

Notice how conventional medicine gathers information and gets better as
new information comes in.

When's the last time you saw alternative medicine say something might
not be safe?


Jeff, being in the sales end of the business, this info is not all
that new from
article

"Serevent's use has fallen dramatically since original reports of
asthma deaths came to light a few years back. But it is one ingredient
in Glaxo's blockbuster asthma drug Advair, and the new worries could
impact that drug, which had $6.8 billion in 2006 global sales.

At least two panel members said the data was so convincing that
Serevent should be pulled from the market. The FDA said it will
consider the safety of all drugs in the class, called long-acting beta
agonists, at a future meeting.

"The members of this committee think this is an urgent public health
issue," panel chairwoman Dr. Marsha Rappley, a neurology and
psychiatry expert at Michigan State University, said.''.....

........Advair contains Serevent plus a steroid. One theory suggests
that the steroid provides a protective effect against the negative
impact of Serevent, but panel members rejected that idea.

"There is not evidence that the steroid mitigates the risk of asthma-
related deaths in patients" taking Serevent, Rappley said.



When and if the FDA agrees with it's own expert panel and ACTS then
you can talk about improvement. I expect not much will be done .
Thanks Vince

bigvince wrote:
On Nov 30, 9:34 am, Jeff wrote:
bigvince wrote:
Glaxo asthma drug needs kid risk warning-FDA panel
By Kim Dixon Thursday, November 29, 2007; 4:27 AM
GAITHERSBURG, Md. (Reuters) - U.S. regulatory advisers on Wednesday
recommended strengthening safety warnings on GlaxoSmithKline Plc's
asthma drug Serevent amid new reports of deaths in children taking the
drug.......
........The data is very troubling because both the increase in
hospitalization and in mortality is so different" from what doctors
currently believe, said Thomas Newman, an epidemiologist at the
University of California, San Francisco, and panel member........
.......At least two panel members said the data was so convincing that
Serevent should be pulled from the market. The FDA said it will
consider the safety of all drugs in the class, called long-acting beta
agonists, at a future meeting.... http://www.healthcentral.com/allergy...196410-66.html
Will the FDA move on this drug . Probably not.
Thanks Vince
You're welcome.

Notice how conventional medicine gathers information and gets better as
new information comes in.

When's the last time you saw alternative medicine say something might
not be safe?


Jeff, being in the sales end of the business, this info is not all
that new from
article

"Serevent's use has fallen dramatically since original reports of
asthma deaths came to light a few years back. But it is one ingredient
in Glaxo's blockbuster asthma drug Advair, and the new worries could
impact that drug, which had $6.8 billion in 2006 global sales.

At least two panel members said the data was so convincing that
Serevent should be pulled from the market. The FDA said it will
consider the safety of all drugs in the class, called long-acting beta
agonists, at a future meeting.

"The members of this committee think this is an urgent public health
issue," panel chairwoman Dr. Marsha Rappley, a neurology and
psychiatry expert at Michigan State University, said.''.....

.......Advair contains Serevent plus a steroid. One theory suggests
that the steroid provides a protective effect against the negative
impact of Serevent, but panel members rejected that idea.

"There is not evidence that the steroid mitigates the risk of asthma-
related deaths in patients" taking Serevent, Rappley said.



When and if the FDA agrees with it's own expert panel and ACTS then
you can talk about improvement. I expect not much will be done .
Thanks Vince

When's the last time you saw alternative medicine say something might
not be safe?

Jeff