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Lansdale, PA
To the Editor:
I read with interest the recent editorial by Schulman (1) and the accompanying article by Rajchert el al. (2) regarding serious bronchospasm due to rapacuronium and its withdrawal by the U.S. Food and Drug Administration (FDA).
Schulman states: "The withdrawal from the market of a previously approved drug is not a novel event." This is an understatement (3). In fact, rapacuronium is the 13th medication or vaccine to be withdrawn by the FDA since 1997. The others are Baycol, Duract, Hismanil, Lotronex, Pondimin, Posicor, Propulsid, Redux, Seldane, Raxar, RotaShield, and Rezulin.
Schulman also states "Phase IV begins once a new drug application is approved and the drug is on the market." Indeed, it is important for clinicians to note that when a new medication is firs. marketed, it is in phase IV of development and testing. Thus, the first patients to receive a newly released medication are actually participating in the research and development process although they and their physicians are usually unaware of this (4).
Prior to marketing, a new medication has usually been tested on a relatively small number of individuals who generally have a limited number of concomitant diseases and who take few concurrent medications (4). After release, however, significantly more patients, having a variety of concurrent medical conditions and who take various other medications generally use the new drug. Thus, it is after releas. that the side effects of a new medication will often become apparent.
For these reasons, and in view of the FDA’s less than exemplary record of screening new medications, it has been recommended that new drugs should not be utilized until they have been marketed for 5 years unless they offer a major improvement over existing medications. This has been termed the "5-year rule" (5). It should have been applied to Rapacuronium.
Footnotes
Dr. Schulman does not wish to respond.
References
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