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Healthy Skepticism Library item: 10494

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

 

Publication type: Journal Article

Tanne JH.
FDA places 'black box' warning on antidiabetes drugs
BMJ 2007 Jun 16; 334:(7606):1237
http://www.bmj.com/cgi/content/full/334/7606/1237


Abstract:

The US Food and Drug Administration has asked the makers of two antidiabetes drugs-rosiglitazone (marketed as Avandia), made by GlaxoSmithKline, and pioglitazone (Actos), made by Takeda-to place “black box” warnings, the most serious kind, on their labels.

The new labels warn of an increased risk of congestive heart failure, because rosiglitazone and related drugs can cause fluid retention. Andrew von Eschenbach, the FDA’s commissioner, announced the warning at a hearing of the US House of Representatives’ Committee on Oversight and Government Reform last week to examine the FDA’s role in evaluating the safety of rosiglitazone.

The new labels do not address the question of whether these drugs pose an increased risk of heart attacks and strokes.

The cardiovascular risk was raised last month by an article and accompanying editorial in the New England Journal of Medicine (doi: 10.1056/NEJMoa072761). Steven Nissen and Kathy Wolski of the Cleveland Clinic did a . . .

 

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Far too large a section of the treatment of disease is to-day controlled by the big manufacturing pharmacists, who have enslaved us in a plausible pseudo-science...
The blind faith which some men have in medicines illustrates too often the greatest of all human capacities - the capacity for self deception...
Some one will say, Is this all your science has to tell us? Is this the outcome of decades of good clinical work, of patient study of the disease, of anxious trial in such good faith of so many drugs? Give us back the childlike trust of the fathers in antimony and in the lancet rather than this cold nihilism. Not at all! Let us accept the truth, however unpleasant it may be, and with the death rate staring us in the face, let us not be deceived with vain fancies...
we need a stern, iconoclastic spirit which leads, not to nihilism, but to an active skepticism - not the passive skepticism, born of despair, but the active skepticism born of a knowledge that recognizes its limitations and knows full well that only in this attitude of mind can true progress be made.
- William Osler 1909