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The strong association between aspirin use in children with chickenpox or influenza-like illnesses and the subsequent development of Reye's syndrome is well-described.1-6 Public health efforts to decrease the use of aspirin (a nonsteroidal antiinflammatory drug) in children with chickenpox or influenza-like illnesses preceded the decline in Reye's syndrome reporting in the United States; this decline during the period 1981 through 1997 was recently summarized by the Centers for Disease Control (CDC).7 In 1980, there were reports of the possible relationship between aspirin use and Reye's syndrome.1,8,9 In 1982, the Surgeon General advised against the use of salicylates and salicylate-containing medications for children with influenza and chickenpox.10 An additional reduction in reporting of Reye's syndrome was observed in 1986 after the Food and Drug Administration (FDA) required the inclusion of a Reye's syndrome warning on the labeling of oral and rectal over-the-counter (OTC) aspirin and aspirin-containing drug products for human use.11 This warning states, "WARNING: Children and teenagers should not use this medicine for chicken pox or flu symptoms before a doctor is consulted about Reye syndrome, a rare but serious illness."
In 1989, McNeil Consumer Healthcare began marketing prescription pediatric ibuprofen. In 1993, at a pre-New Drug Application meeting with the FDA to discuss the possibility of OTC approval for pediatric ibuprofen, the issue was raised whether use of ibuprofen, also a nonsteroidal antiinflammatory drug, in children with chickenpox or influenza posed an increased risk of Reye's syndrome. To address this issue, McNeil reviewed and presented data at an FDA Advisory Committee Meeting in March 1995, which indicated that there was no evidence during the marketing of prescription pediatric ibuprofen to suggest any increased risk of Reye's syndrome. In the McNeil-sponsored...