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
Starko KM, Ray CG, Dominguez LB, Stromberg WL, Wodall DF.
Reye's
syndrome and salicylate use. Pediatrics 1980;66:859-864.
Waldman, RJ, Hall WN, McGee H, van Amburg G: Aspirin as a risk
factor in Reye's syndrome. JAMA 1982;247:3089-94.
CDC. National surveillance of Reye syndrome 1981: Update, Reye
syndrome and salicylate usage. MMWR 1982;31:53-6.
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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