FDA is incapable of protecting US "against another Vioxx"

doi:10.1136/bmj.329.7477.1253

BMJ 2004;329:1253 (27 November), doi:10.1136/bmj.329.7477.1253

News

FDA is incapable of protecting US "against another Vioxx"

Jeanne Lenzer

New York

The first 150 words of the full text of this article appear below.

The approval of rofecoxib (Vioxx) by the US Food and Drug Administrationhas led to the "single greatest drug safety catastrophe in thehistory of this country or the history of the world," chargedone of the agency's own experts, Dr David Graham, in US Senatehearings last Thursday.

Dr Graham, associate director in the FDA's Office of Drug Safety,said an estimated 88 000 to 139 000 Americans had heart attacksand strokes as a result of taking rofecoxib. The number, hesaid, far exceeds earlier disasters such as the 100 childrenkilled in the United States by an elixir of sulfanilamide inthe 1930s and the 5000 to 10 000 children born in the 1960swith birth defects related to thalidomide. Both events led tosweeping regulatory changes in the United States.

Senator Charles Grassley, chairman of the Senate's finance committee,opened the hearings on the FDA and . . . [Full text of this article]

-->
Add to CiteULike CiteULike Add to Complore Complore Add to Connotea Connotea Add to Del.icio.us Del.icio.us Add to Digg Digg Add to Reddit Reddit Add to Technorati Technorati What's this?

Relevant Articles

Drug safety and regulation: Patrick C Waller, Stephen J W Evans, and Keith Beard
BMJ 2005 331: 4-5. [Extract] [Full Text] [PDF]

Europe also needs agency for postmarketing surveillance: Silvio Garattini
BMJ 2005 330: 540. [Extract] [Full Text]

Save the FDA: Alexander S D Spiers
BMJ 2005 330: 308. [Extract] [Full Text] [PDF]

Is drug regulation failing?: Kamran Abbasi
BMJ 2004 329: 0. [Extract] [Full Text] [PDF]

Drug maker urges group to lobby FDA on testosterone for women: Ray Moynihan
BMJ 2004 329: 1255. [Extract] [Full Text] [PDF]

This article has been cited by other articles:

Waller, P. C, Evans, S. J W, Beard, K. (2005). Drug safety and regulation. BMJ 331: 4-5 [Full text]
Garattini, S. (2005). Europe also needs agency for postmarketing surveillance. BMJ 330: 540-540 [Full text]
Spiers, A. S D (2005). Save the FDA. BMJ 330: 308-308 [Full text]
(2005). Robin Goodfellow (44-2). Rheumatology (Oxford) 44: 267-267 [Full text]
Schoenberger, C. (2004). Pitfalls on the road to drug safety. BMJ 329: 1411-1411 [Full text]
Kmietowicz, Z. (2004). Website aims to distance doctors from drug firms. BMJ 329: 1409-1409 [Full text]

Rapid Responses:

Read all Rapid Responses

Vioxx was Over Prescibed by Doctors in the UK: des spence
bmj.com, 29 Nov 2004 [Full text]
Re: Vioxx was Over Prescibed by Doctors in the UK: Brian J. Penney
bmj.com, 30 Nov 2004 [Full text]
Over prescribing of Vioxx: des spence
bmj.com, 1 Dec 2004 [Full text]
Vioxx is just one that got caught: Dr. Herbert H. Nehrlich
bmj.com, 2 Dec 2004 [Full text]
A Comment on the Use of FluMist(R) for Children and Adults: Walter R Schumm
bmj.com, 3 Dec 2004 [Full text]
Rofecoxib: Silvio Garattini
bmj.com, 18 Feb 2005 [Full text]