'Approval from the U.S. Food and Drug Administration (FDA) does not necessarily ensure that a drug has a large or important benefit, or that all serious adverse effects of the drug are known, according to background information in the article. "Uncertainties are greatest in the first few years after approval and for drugs approved solely on the basis of a surrogate outcome," the authors note.
They point out that the cholesterol-lowering drugs Zetia and Vytorin reached $1.8 billion in sales in 2007 before a study found no clinical benefit from these drugs, and that the anti-inflammatory medication Vioxx reached $2.4 billion in sales by 2003 before being withdrawn from the market due to its association with myocardial infarctions (heart attacks) and strokes.
' "The FDA has never required advertisements to acknowledge uncertainties inherent in all new drugs," write the authors. "Enthusiasm for Zetia and Vioxx … might have been dampened had consumers known to look for drugs approved based on patient outcomes or drugs with a longer safety record." '
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