Failing the public health--rofecoxib, Merck, and the FDA.
نویسنده
چکیده
On May 21, 1999, Merck was granted approval by the Food and Drug Administration (FDA) to market rofecoxib (Vioxx). On September 30, 2004, after more than 80 million patients had taken this medicine and annual sales had topped $2.5 billion, the company withdrew the drug because of an excess risk of myocardial infarctions and strokes. This represents the largest prescription-drug withdrawal in history, but had the many warning signs along the way been heeded, such a debacle could have been prevented.
منابع مشابه
Commentary: Epidemiology and the pharmaceutical industry: an inside perspective.
at the FDA. Lancet 2004;364:1995–96. 59 Topol EJ. Failing the public health Rofecoxib, Merck, and the FDA. N Engl J Med 2004;351:1707–9. 60 Last JM. Guidelines on ethics for epidemiologists. Int J Epidemiol 1990;19:226–29. 61 Neutra RR, Cohen A, Fletcher T, Michaels D, Richter ED, Soskolne CL. Toward guidelines for the ethical reanalysis and reinterpretation of another’s research. Epidemiology ...
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ورودعنوان ژورنال:
- The New England journal of medicine
دوره 351 17 شماره
صفحات -
تاریخ انتشار 2004