Copyright 2002 American Medical Association. All Rights Reserved.
Applicable FARS/DFARS Restrictions Apply to Government Use.2002
To the Editor: It is not surprising that Dr
Lasser and colleagues1 found that serious
ADRs are commonly discovered after the FDA has approved a new drug. The inherent
limitations of clinical trials (ie, relatively small size, generally narrow
study populations, narrow indication, and relatively short duration) significantly
affect their ability to detect rare, serious ADRs,2
and are the raison d'être for postmarketing medical product monitoring.
Similarly, it is known that a striking (at times, exponential) increase in
patient exposure can occur once a drug comes to market. Patient populations
(perhaps even an entire sex) who comprised little or none of the premarketing
study group may undergo treatment with the drug.3
Goldman SA. Postmarketing Surveillance and Black Box Warnings. JAMA. 2002;288(8):955-959. doi:10.1001/jama.288.8.955