Stronger Warning Label on Aspirin Urged : House Subcommittee Wants Link to Reye’s Syndrome Mentioned

The House Energy and Commerce subcommittee on health, calling the aspirin industry’s voluntary labeling program inadequate, voted Wednesday to require explicit messages on all aspirin containers warning of the association between the drug and the often-fatal Reye’s syndrome in children and teen-agers.

The subcommittee also voted to require warning labels for smokeless tobacco--chewing tobacco and snuff--and to prohibit broadcast advertising of the products.

Children’s Tobacco Use

The action, approved by a vote of 16 to 2, was prompted by testimony reporting increasing use of the tobacco products by children and teen-agers, apparently in response to television advertising featuring athletes and entertainers. Surgeon General C. Everett Koop and the National Cancer Institute have said the use of smokeless tobacco increases the risk of cancers of the mouth, pharynx and esophagus.

The aspirin labeling measure, approved 9 to 7, would require all manufacturers to place the following message on their products: “Warning. For children or teen-agers, before using this product for chicken pox or influenza or flu symptoms, consult a doctor. Aspirin may increase the risk of developing Reye’s syndrome, a rare but serious illness.”

The American Academy of Pediatrics supports the use of the stronger warning label.

Reye’s syndrome is characterized by the sudden onset of vomiting, often accompanied by fever and sometimes by lethargy, severe headaches and changes in behavior. It can progress quickly to convulsions, delirium and coma and is fatal in 20% to 30% of cases.

The current labels, which major aspirin manufacturers have been placing on containers during the last eight months, read: “Consult a physician before giving this medicine to children, including teen-agers, with chicken pox or flu.”

The voluntary labeling program was begun at the request of Health and Human Services Secretary Margaret M. Heckler last January after a study by the federal Centers for Disease Control found that children and teen-agers suffering from flu or chicken pox were 12 to 25 times more likely to develop Reye’s syndrome than sick children who were not given the drug.

Evidence Called Insufficient

Dr. Joseph White, president of the Aspirin Foundation of America, contending that there is still insufficient evidence that aspirin use leads to Reye’s syndrome, called the subcommittee’s proposed label “very poor information to give the public.”

“If you don’t have proof that something might happen, you don’t suggest it on the label,” he said. “You don’t name something.”

Subcommittee Chairman Henry A. Waxman (D-Los Angeles), however, called the current label “one of the stupidest warnings I’ve ever seen” because “it communicates nothing to anyone. No one whose child has a fever is going to call a doctor in the middle of the night after reading that label. A parent will want to do something to reduce the fever and give the aspirin anyway--maybe with fatal results.”