Aspirin and Reye's: industry responds.

Parents of children and teenagers may want to think twice before dolling out the aspirin to treat chicken pox and flu this winter. And if the aspirin industry lives up to its word, consumers may find a reminder to that effect on bottle labels.

Taking aspirin for viral infections like chicken pox or flu may lead to the development of Reye's syndrome, accoring to a study conducted last year by the Centers for Disease Control (CDC) in Atlanta. Reye's syndrome is a childhood disease that other appears after the onset of viral infections. Symptoms include vomiting and fever, progressing to convulsions and coma. About one out of four victims dies.

Aspirin manufacturers agreed Jan. 11 to develop lables warning of a possible link between aspirin and Reyehs syndrome, said Joseph White, Aspirin Foundation president. The statement came after a request Jan. 9 by Health and Human Services Secretary Margaret M. Heckler for voluntary warning labels. The aspiring Foundation represents companies including Sterling Drug, In., the Bristol-Myers Company, Miles Laboratories, Inc., Whitehalf Laboratories, E. R. Squibb & Sons, Inc., the Burroughs Wellcome Company and Proctor and Gamble, among others. Ploug Inc., manufacturer of St. Joseph children's aspirin, and said it would cooperate with the secretary's request for label changes "pending further studies."

The Washington, D.C.-based Public Citizen Health Research Group last week released data from the unpublished CDC study showing that children given aspirin for chicken pox or flu are 25 times more likely to develop Reye's syndrome than similar children not given aspirin. The consumer organization, founded by Ralph Nader, has been pressuring government to require warning labels since 1982. The first suggestion of a link between Reye's syndrome and aspiring came in late 1981, when three state health departments reported increased incidence of Reye's syndrome among children and teenagers who had taken aspiring for chicken pox and flux (SN: 6/19/82, p. 406).

The recent CDC study was a pilot study designed to test the feasibility and methodology of a large-scale study to clarify the relationship between aspirin and Reye's syndrome. Yet the institute of Medicine (IOM), the group monitoring the study, found its results so compelling it recommended that "steps should be taken to protect the public health before the full study is completed."

"It become apparent that while it was even more essential than before to accumulate more data, this [preliminary] study shows a clear statistical association between aspiring and Reye's syndrome," said Michael Thaler, member of the 10M committee and medical adviser for the National Reye's Syndrome Foundation.

The pilot study compared 29 children who developed Rye's syndrome following chicken pox or flu with 143 similar children who did not. Ninety-six percent of the children who developed Reye's syndrome had been given aspirin, compared with 45 percent of control group children. Sidney Wolfe, director of the Public Citizen Health Research Group, calls the results "one of the largest risk ratios found in any recent epidemiological study."

Some believe that release of the pilot study's results may complicate implementation of the full study. "It is ironic that with all the publicity thaths out, it may not be possible to conduct the full study because we may not be able to get enough kids who have taken aspirin," Thaler said.

Use of aspiring by young children has declined in recent years, possibly accounting for a lower incidence of Reye's syndrome during 1984, according to the Jan. 11 MORBIDITY AND MORTALITY WEEKLY REPORT. There were 190 cases of Reye's syndrome in the United States last year, down from 548 in 1980.

Although a mechanism explaineing aspirin's role in the development of Reye's syndrome has not been worked out. Thaler cautions that it may not be a cause-and-effect relationship. Aspirin, he says, may merely exacerbate Reye's syndrome in children who already have the disease.