Vioxx, the implosion of Merck, and aftershocks at the FDA.
نویسنده
چکیده
منابع مشابه
Worldwide drug withdrawal puts FDA under scrutiny Merck faces 300 lawsuits Karen
Vioxx is a cyclooxygenase (COX)-2 selective, non-steroidal anti-inflammatory drug (NSAID) that was approved by the USA’s Food and Drug Administration (FDA) in May 1999 for the relief of the signs and symptoms of osteoarthritis, the management of acute pain in adults, and the treatment of menstrual symptoms. Vioxx was later also approved for the relief of signs and symptoms of rheumatoid arthrit...
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The new england journal of medicine 2875 correspondence Rofecoxib, Merck, and the FDA to the editor: Merck has been proactive and conscientious in evaluating the cardiovascular profile of rofecoxib (Vioxx); Dr. Topol's remarks to the contrary in his Perspective article (Oct. 21 issue) 1 are false. First, his description of the time line obfus-cates the facts. The Food and Drug Administration (F...
متن کاملFailing the public health--rofecoxib, Merck, and the FDA.
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 hi...
متن کاملEthical considerations in studying drug safety--the Institute of Medicine report.
The tumult arising from revelations of serious safety risks associated with widely prescribed drugs, including rosiglitazone (Avandia, GlaxoSmithKline), rofecoxib (Vioxx, Merck), and celecoxib (Celebrex, Pfizer), has led to widespread recognition that improvement is needed in our national system of ensuring drug safety. Notwithstanding federal legislation in 2007 that strengthened the authority...
متن کاملThe use of nonsteroidal anti-inflammatory drugs (NSAIDs): a science advisory from the American Heart Association.
Recent clinical trial data have raised questions about the degree to which patients and their physicians should consider an increased risk of cardiovascular or cerebrovascular events when selecting medications for pain relief. In September 2004, Merck announced a voluntary worldwide withdrawal of Vioxx (rofecoxib) because of an increased risk of heart attack and stroke. In early December 2004, ...
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ورودعنوان ژورنال:
- Lancet
دوره 364 9450 شماره
صفحات -
تاریخ انتشار 2004