Title |
Decisions by regulatory agencies: are they evidence-based?
|
---|---|
Published in |
Trials, April 2007
|
DOI | 10.1186/1745-6215-8-13 |
Pubmed ID | |
Authors |
Curt D Furberg |
Abstract |
Contradictory statements about the non-steroidal anti-inflammatory drugs from the European Medicines Agency and the United States Food and Drug Administration have raised questions about whether regulatory decisions are evidence-based. For the selective COX-2 inhibitors, there are clear contraindications and warnings in Europe, but only a vaguely worded Black Box warning in the United States. All the non-selective agents are given an almost "clean bill of health" in Europe, while all of them are judged to have a similar risk-benefit ratio as celecoxib in the United States. The regulatory agencies have failed to recognize the clinical trial evidence that the risk of cardiovascular events varies substantially among the non-selective agents, with diclofenac carrying the highest risk of harm. |
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