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Executive Summary

REYE's SYNDROME WARNING ON ASPIRIN LABELS WOULD BE "PRUDENT" policy to discourage aspirin use in children with flu or chicken pox, a recent telephone survey contracted by FDA on consumer awareness of Reye's Syndrome concluded. The four authors of the study, Louis Morris, PhD, Ronald Klimberg, Evelyn Gordon, PhD, and Janet Arrowsmith, MD, suggested that "even without the results of the present study, a warning on the label would be considered a prudent and consistent policy if one wished to discourage the use of aspirin for children with flu or chicken pox." The nationwide study polled 1,155 parents of children aged 19 years or younger. Of the parents surveyed, 53% "knew that aspirin should not be used by children with flu or chicken pox and 40% of the sample spontaneously recalled Reye's Syndrome as the reason for the contraindication," the study reports. Radio or TV programs were cited by 62% of the respondents as contributing to their knowledge about giving aspirin to children with flu or chicken pox. Magazines or newspapers were cited by 60%, friends or family by 48%, radio or TV public service announcements by 48%, doctor by 47%, advertisement by 26%, label by 19%, and poster by 13%. "The mean number of sources mentioned by subjects saying they had heard something about giving aspirin to children was 3.2," the researchers reported. In their analysis of the survey results, the researchers cited newspapers and magazines as the "single, strongest predictor of promoting knowledge" about Reye's Syndrome. "Although as many subjects said they learned about Reye's Syndrome from TV programming as they did from magazines/newspapers, TV programming was not significantly related to knowledge about Reye's Syndrome," the authors asserted. They explained that "TV might have been a useful way to make people initially aware of Reye's Syndrome but that greater understanding and knowledge flowed from additional sources that more fully explained the specifics of the disease." The report notes that although "the label and poster were infrequently mentioned" as sources of information on the childhood disease, the label warning "has only recently been added to most aspirin labels." Based on the survey, the study authors concluded that "multiple sources of information (not only a warning label) must be considered in any new public education campaign." The report also suggests that while "the physician's intervention may be the best source of advice . . . for those parents who continue to believe that aspirin is an appropriate medication for children with flu or chicken pox," a Reye's Syndrome warn ing "label may be considered a useful part of a broader campaign because of its potential for reaching people who have not yet been exposed to other media; and if read, it may help convince people that aspirin is not appropriate for use by children with flu or chicken pox." Addressing the issue of which children are more likely to receive aspirin for flu or chicken pox, the researchers reported that the "strongest discriminating factor" of the 12% of surveyed parents who said they would "give their children aspirin if they were to have the flu or chicken pox today . . . was the age of the oldest child." Because parents of older children "may not realize that the Reye's Syndrome warning applies to teenagers (age 10-19) as well as children under 10 years old," the authors suggest that "increased emphasis of the Reye Syndrome warning for teenagers seems warranted." The researchers added that since "the degree to which teenagers self-medicate is not known . . . informational programs directed to both teens and their parents would appear appropriate."

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