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Betreff:
Glitazones....Avandia....black
box warning negotiations..6 7 07.... |
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Von: JCMPelican @aol.com |
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Datum: Sun, 10 Jun 2007 16:32:24 EDT |
RE: BLACK BOX WARNINGS ON PRESCRIPTION
MEDS
The diabetes medication Avandia has now been added to
the growing list of medications related to promotion of various heart
problems.
As most persons know, the list of medications (whether
reaching "black box status" or not) includes cholesterol-lowering
statins, various products re weight reduction,
arthritis, medications and now diabetes medications -- all adversely
connected to various heart problems and in the instance of statins, in
particular, decline in memory and cognitive function. Suicide
has been reported as one of the many adverse events following various
tranquilizers and other medications for depression.
In this instance re the glitazone Avandia, "negotiations"
are underway between the pharmaceutical companies and the U.S. Food and Drug
Administration. Exactly what sort of "negotiations" will
negate adverse effects that can lead to death?
What sort of "caution" can a person who is
suffering from diabetes or other maladies practice? Are the
people supposed to "comply with physicians' recommendations" while
awaiting additional statistics all the while "becoming statistics....?"
WHEN will the FDA, government and industry decide to
consider EMF/EMR-related toxicity as a primary contributor to the rapid decline
in tolerance of all medications?
Best wishes to all for good health "in spite of
such ignorance...." Joanne
Joanne C. Mueller
Guinea Pigs R Us
731 - 123rd Avenue N.W.
Minneapolis, Minnesota 55448-2127 USA
Phone: 763-755-6114
Email: jcmpelican@aol.com (6-10-07)
"No substance is a poison by itself. It is the dose that makes a
substance a poison..." Paracelsus (1493-1541)
Physician's First
Watch for June 7, 2007
David G. Fairchild, MD, MPH,
Editor-in-Chief
FDA
Asks for Black-Box Warning on Heart Failure Risk with Glitazones
FDA Asks for Black-Box Warning on Heart Failure Risk
with Glitazones
In Congressional testimony yesterday, the FDA
commissioner revealed that the agency has requested that the manufacturers of
rosiglitazone (Avandia) and pioglitazone (Actos) add black-box warnings about
the risk for heart failure with these drugs.
The commissioner indicated that the request was made
because although the drugs currently carry warnings about potential heart
failure, they are still sometimes prescribed to patients with this condition.
The request was only made public yesterday but was
made to the companies on May 23, a couple of days after the publication of a
meta-analysis that raised questions about the potential risk for heart attacks
with rosiglitazone. The manufacturers have indicated that they are in
negotiations with the agency over the new warnings.
New York Times story (One-time registration required)
Wall Street Journal story (Subscription required)
Related Journal Watch link(s):
Physician's First
Watch coverage
of interim analysis (Free)