2003N-0342 - Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products
FDA Comment Number : EC1
Submitter : Mr. Tom Moberly Date & Time: 07/19/2004 05:07:09
Organization : Clinical Researcher
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Issue Areas/Comments
GENERAL
GENERAL
Clinical Researcher (<www.clinical-researcher.com>) has received some correspondence about the use of the term "side effect" rather than "adverse event" in "Toll-free number for reporting adverse events on labeling for human drug products" and I wanted to bring your attention to these comments.

Whilst the reasons (in terms of patient understanding) for using "side effect" rather than "adverse event" are set out clearly in the proposal, there is no discussion of the possible implications that the use of this terminology might have on drug marketing.

For instance, the term "adverse event" suggests a detrimental consequence of the use of the drug, whilst a side effect may present the same risk, it may also indicate an area of efficacy that has not been studied adequately to be promoted as an "indication".

This might, therefore, leave the door open for the promotion of unapproved indications as "side effects".
Such promotion would simply add to the confusion: "weight loss" (or other effects that may be seen as positive or negative depending on the therapeutic group) would appear on the labeling as "side effects", rather than "adverse events".

It would, therefore, be worthwhile taking steps to make sure that this attempted clarification does not cause more problems than it solves.