Betreff: box warning negotiations..6 7 07....

Von: JCMPelican

Datum: Sun, 10 Jun 2007 16:32:24 EDT




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:   (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

ArrowFDA 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)

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Physician's First Watch coverage of interim analysis (Free)