From: Citizen Jimserac on
http://www.witn.com/health/headlines/84941117.html

Thunk!

Citizen Jimserac
From: Jan Drew on
On Feb 22, 2:23 pm, Citizen Jimserac <jimse...(a)gmail.com> wrote:
> http://www.witn.com/health/headlines/84941117.html
>
> Thunk!
>
> Citizen Jimserac

83,000 Heart Attacks
Senators Max Baucus and Charles Grassely released a report claiming
that GlaxoSmithKline knew of possible cardiac risks linked to their
diabetes drug Avandia.

According to the report the FDA allowed the company to continue its
clinical run of Avandia after the drug had already caused an estimated
83,000 heart attacks.

The Food and Drug Administration will ask an advisory panel to
reconsider the risks of Avandia, which is Glaxo's second best selling
product.

Concerns about Avandia were raised in 2007 when researchers with The
Cleveland Clinic released a study claiming there was a link between
the drug and heart attacks.

Officials with GlaxoSmithKline maintain that Avandia is safe.

http://www.drugs.com/sfx/avandia-side-effects.html

http://www.fda.gov/NewsEvents/Testimony/ucm153838.htm

Approved 1999

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2007/ucm109026.htm

FDA NEWS RELEASE


This is a revised version of a FDA Press Release, originally issued
November 14, 2007.
Revisions have been made to correct the title from "Heart Attacks to
Heart-related Risk.


FOR IMMEDIATE RELEASE
November 14, 2007
Media Inquiries:
Susan Cruzan, 301-827-6242
Consumer Inquiries:
888-INFO-FDA


FDA Adds Boxed Warning for Heart-related Risks to Anti-Diabetes Drug
Avandia
Agency says drug to remain on market, while safety assessment
continues
The U.S. Food and Drug Administration announced today that the
manufacturer of Avandia (rosiglitazone), a drug used to treat type 2
diabetes, has agreed to add new information to the existing boxed
warning in the drug's labeling about potential increased risk for
heart attacks.

People with type 2 diabetes who have underlying heart disease or who
are at high risk of heart attack should talk with their health care
provider about the revised warning as they evaluate treatment options.
FDA advises health care providers to closely monitor patients who take
Avandia for cardiovascular risks.

"FDA has moved expeditiously to review the cardiovascular risks of
this drug so that we could inform patients and doctors at the earliest
possible time of our findings," said Janet Woodcock, M.D., FDA's
deputy commissioner for scientific and medical programs, chief medical
officer, and acting director of the Center for Drug Evaluation and
Research. "FDA remains committed to making sure that doctors and
patients have the latest information about the risks and benefits of
medicines."

Avandia, manufactured by GlaxoSmithKline (GSK), Philadelphia, Pa., was
approved in 1999 as an adjunct to diet and exercise to improve control
of blood sugar levels. Avandia is approved to be used as a single
therapy or used in combination with metformin and sulfonylureas, other
oral anti-diabetes treatments.

During the past year, FDA has carefully weighed several complex
sources of data, some which show conflicting results, related to the
risk of chest pain, heart attacks and heart-related deaths, and deaths
from any cause in patients treated with Avandia.

At this time, FDA has concluded that there isn't enough evidence to
indicate that the risks of heart attacks or death are different
between Avandia and some other oral type 2 diabetes treatments.
Therefore, FDA has requested that GSK conduct a new long-term study to
evaluate the potential cardiovascular risk of Avandia, compared to an
active control agent. GSK has agreed to conduct the study and FDA will
ensure it is initiated promptly.

The revision of Avandia's existing boxed warning – FDA's strongest
form of warning – includes the following statement:

A meta-analysis of 42 clinical studies (mean duration 6 months; 14,237
total patients), most of which compared Avandia to placebo, showed
Avandia to be associated with an increased risk of myocardial ischemic
events such as angina or myocardial infarction. Three other studies
(mean duration 41 months; 14,067 patients), comparing Avandia to some
other approved oral antidiabetic agents or placebo, have not confirmed
or excluded this risk. In their entirety, the available data on the
risk of myocardial ischemia are inconclusive.

The previous upgraded warning, added to certain diabetes drugs (in
class of drugs related to Avandia) on Aug. 14, 2007, emphasized that
these types of drugs may worsen heart failure, a condition in which
the heart does not adequately pump blood, in some patients.
GSK is also developing a Medication Guide for patients to provide
additional information about the benefits and risks and safe use of
Avandia.

To date, no oral anti-diabetes drug has been conclusively shown to
reduce cardiovascular risk. Consequently, the agency also will be
requesting that labeling of all approved oral anti-diabetes drugs
contain language describing the lack of data showing this benefit.

Today's action follows recommendations made at the July 2007 joint
meeting of FDA's Endocrine and Metabolic Drugs and Drug Safety and
Risk Management Advisory Committees. At the meeting, members voted
22-1 to recommend that Avandia stay on the market, pending a review of
additional data. The committee also advised that information warning
of the potential for increased risk of heart attacks should be added
to the drug labeling.


For more information:
Rosiglitazone maleate (marketed as Avandia, Avandamet, and Avandaryl)
Information
www.fda.gov/cder/drug/infopage/rosiglitazone/default.htm
FDA Issues Safety Alert on Avandia
www.fda.gov/bbs/topics/NEWS/2007/NEW01636.html
#


RSS Feed for FDA News Releases1 [what is RSS?2]



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http://www.fda.gov/ScienceResearch/SpecialTopics/WomensHealthResearch/ucm134225.htm

FDA Issues Safety Alert on Avandia

From: Peter B on

"Jan Drew" <jdrew63929(a)aol.com> wrote in message
news:46bbdde5-9238-4698-b1ab-512a12c712f1(a)15g2000yqi.googlegroups.com...
On Feb 22, 2:23 pm, Citizen Jimserac <jimse...(a)gmail.com> wrote:
> http://www.
>
The revision of Avandia's existing boxed warning - FDA's strongest
form of warning - includes the following statement:

A meta-analysis of 42 clinical studies (mean duration 6 months; 14,237
total patients), most of which compared Avandia to placebo, showed
Avandia to be associated with an increased risk of myocardial ischemic
events such as angina or myocardial infarction. *Three other studies
(mean duration 41 months; 14,067 patients), comparing Avandia to some
other approved oral antidiabetic agents or placebo, have not confirmed
or excluded this risk.* * In their entirety, the available data on the
risk of myocardial ischemia are inconclusive.*

The previous upgraded warning, added to certain diabetes drugs (in
class of drugs related to Avandia) on Aug. 14, 2007, emphasized that
these types of drugs may worsen heart failure, a condition in which
the heart does not adequately pump blood, in some patients.
GSK is also developing a Medication Guide for patients to provide
additional information about the benefits and risks and safe use of
Avandia.

*To date, no oral anti-diabetes drug has been conclusively shown to
reduce cardiovascular risk*. Consequently, the agency also will be
requesting that labeling of all approved oral anti-diabetes drugs
contain language describing the lack of data showing this benefit.
==============================================
The important parts of this article do not support your fear, especially
with one product.


From: Happy Oyster on
On Mon, 22 Feb 2010 11:23:52 -0800 (PST), Citizen Jimserac <jimserac(a)gmail.com>
wrote:

>http://www.witn.com/health/headlines/84941117.html
>
>Thunk!
>
>Citizen Jimserac

Yes, that seems to go down the drain.

..
--
Die volle H�rte: http://www.kindersprechstunde.at
***************************************************************
Die Medienmafia � Die Regividerm-Verschw�rung
http://www.transgallaxys.com/~kanzlerzwo/showtopic.php?threadid=5710
From: Happy Oyster on
On Mon, 22 Feb 2010 16:22:15 -0800 (PST), Jan Drew <jdrew63929(a)aol.com> wrote:

>On Feb 22, 2:23�pm, Citizen Jimserac <jimse...(a)gmail.com> wrote:
>> http://www.witn.com/health/headlines/84941117.html
>>
>> Thunk!
>>
>> Citizen Jimserac
>
>83,000 Heart Attacks


Way too much for a person like Jan Drew, who is too damned stupid to even coput
to 2.

..
--
Die volle H�rte: http://www.kindersprechstunde.at
***************************************************************
Die Medienmafia � Die Regividerm-Verschw�rung
http://www.transgallaxys.com/~kanzlerzwo/showtopic.php?threadid=5710