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Surgeon General's Advisory on the Use of Salicylates and Reye Syndrome

Because the use of salicylates such as aspirin for children with influenza and chickenpox has been associated with Reye syndrome, the Surgeon General advises against use of salicylate and salicylate-containing medications for children with these diseases. The association of salicylates with Reye syndrome is based upon evidence from epidemiologic studies that are sufficiently strong to justify this warning to parents and health care personnel.

First recognized about 19 years ago, Reye syndrome is a rare, acute, life-threatening condition characterized by vomiting and lethargy that may progress to delirium and coma. Most commonly it occurs in children who are recovering from viral infections, particularly influenza and chickenpox. The Centers for Disease Control (CDC) estimates that 600-1,200 cases occur each year in the United States, most in persons between the ages of 5 and 16 years. Death occurs in 20%-30% of reported cases, and permanent brain damage has also been reported in survivors.

There have been reports for several years suggesting an association between Reye syndrome and the prior use of common medications. However, the results of recent case-control studies have made it possible to assess the association with specific drugs. These studies conducted by state health departments suggest an association between prior ingestion of aspirin and other salicylates and Reye syndrome. The studies in Arizona and Michigan have been published (1,2). The largest of these studies, conducted in Ohio, is expected to appear shortly in the Journal of the American Medical Association.

The Surgeon General notes that the matter has been reviewed recently by several groups from within and outside government.

  • CDC, on the basis of its review of the available data and the recommendations of an advisory panel on February 12, 1982, stated that "until definitive information is available, CDC advises physicians and parents of the possible increased risk of Reye syndrome associated with the use of salicylates for children with chickenpox and influenza-like illness" (3).

  • The American Academy of Pediatrics' Committee on Infectious Diseases also has reviewed the data, and in the June 1982 issue of Pediatrics issued a statement advising that the use of salicylates should be avoided for children suffering from influenza or chickenpox (4).

  • A Food and Drug Administration (FDA) working group audited the raw data in February 1982 from 3 studies conducted by state health departments (2 in Michigan and 1 in Ohio) and independently analyzed the data. The FDA evaluation was discussed in an open public meeting sponsored by FDA, CDC, and the National Institutes of Health on May 24, 1982. The meeting was attended by invited experts from the academic community, the drug industry, and consumer organizations. It was the consensus of the scientific working group at the completion of the meeting that the new analysis supported the earlier evidence of an association between salicylates and Reye syndrome. As a result of this entire review process, the Surgeon General

advises against the use of salicylates and salicylate-containing medications for children with influenza and chickenpox.*

References

  1. Starko KM, Ray CG, Dominguez LB, Stromberg WL, Wodall DF. Reye's syndrome and salicylate use. Pediatrics 1980;66:859-864.

  2. Waldman, RJ, Hall WN, McGee H, van Amburg G: Aspirin as a risk factor in Reye's syndrome. JAMA 1982;247:3089-94.

  3. CDC. National surveillance of Reye syndrome 1981: Update, Reye syndrome and salicylate usage. MMWR 1982;31:53-6.

  4. Committee on Infectious Diseases, American Academy of Pediatrics. Special report: aspirin and Reye syndrome. Pediatrics 1982;69:810-2. *The Surgeon General notes that the FDA will notify health professionals through its Drug Bulletin, will develop lay-language information for widespread distribution, and will take the steps necessary to establish new labeling requirements for drugs containing salicylates.



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