Industry officials vowed yesterday to fight the government's decision to warn doctors and parents not to use aspirin to treat children with influenza or chicken pox because it might cause a rare and dangerous disease.
Dr. Joseph M. White, president of the Aspirin Foundation of America, said his manufacturers group was stunned by the announcement Friday and "may well" file suit to block a requirement that all aspirin products contain a warning against use in childhood diseases because of a link to Reye's Syndrome, which kills more than 100 children a year in the United States.
White said that the studies linking aspirin use to the syndrome "were so faulty and poorly run they couldn't be subjected to valid statistical analysis. . . . The evidence doesn't warrant this step." He said aspirin is used 90 million times a day. Trade publications estimate it is a $700 million-a-year industry.
Health and Human Services Secretary Richard S. Schweiker made the announcement Friday afternoon. Food and Drug Administration spokesman William Grigg said the matter was considered "of sufficient public interest not to delay the announcement."
FDA will notify doctors of the risk through its Drug Bulletin, start an educational campaign aimed at parents and pharmacists and "require that the labeling of these products be changed to advise against their use in childhood diseases," Schweiker's statement said.
In February, the federal Centers for Disease Control in Atlanta warned about the "possible increased risk" of Reye's Syndrome with aspirin treatment of viral diseases in children.
In May, the Public Health Research Group, started by Ralph Nader, filed suit. In June, a committee of the American Academy of Pediatrics issued its own warning against use of aspirin for such cases.
Cary LaCheen, of the Public Health Research Group, said that her organization was pleased by Schweiker's announcement, especially because the Reagan administration has been reluctant to impose new regulatory burdens on industry.
The labels should suggest alternative treatments, LaCheen said, adding that most childhood fevers don't require drug treatment.
FDA spokesmen said yesterday they weren't sure if such interim steps were being contemplated and didn't know how long the labeling procedure would take. Grigg said FDA wanted the warnings "to be available before the next flu season starts in late fall."
The CDC estimates that between 600 and 1,200 cases of Reye's Syndrome occur each year in this country, mostly in youngsters 5 to 16 years of age. Death results in more than 20 percent of the cases, and permanent brain damage occurs in others.
White of the Aspirin Foundation said his group had proposed financing an independent look at the recent studies and would have agreed to a voluntary warning if the evidence warranted it.
"We wanted a decision," he said. "If there's a real problem we want to label to avoid the possibility someone may proceed with a suit." He added that the government announcement "may well invite" suits against aspirin manufacturers.