‘Agreement in Principle’ Reached on Aspirin Label Telling of Reye’s Syndrome

The Food and Drug Administration has reached “an agreement in principle” with aspirin manufacturers to require mandatory labels on aspirin bottles with new, stronger language warning of the association between the drug and the sometimes fatal Reye’s syndrome in children, congressional sources said Friday.

If approved by Health and Human Services Secretary Margaret M. Heckler and the White House, the new labeling requirement would replace the voluntary labeling program now conducted by the industry. Unlike the current labels, the new language would mention Reye’s syndrome by name.

The new notice would read: “Warning: children and teen-agers should not use this medicine for chicken pox or flu symptoms before consulting a doctor about Reye Syndrome, a rare but serious illness.”

Fatal in 20% of Cases

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 label reads: “Consult a physician before giving this medicine to children, including teen-agers, with chicken pox or flu.”

A consensus on the policy change has been reached among agency officials, Senate Labor and Human Resources Committee Chairman Orrin G. Hatch (R-Utah), the aspirin industry and a key Democrat, Sen. Howard M. Metzenbaum of Ohio, according to Irene Ford-Howard, a spokeswoman for the committee.

The regulation would go into effect next May 30 and would expire two years later unless renewed. The rule would cover all aspirin products used in interstate commerce.

Decision Not Made

“There’s an agreement in principle,” Ford-Howard said. “The ultimate decision rests with the secretary, and that decision hasn’t been made.”

Aspirin industry officials refused to comment on the proposed policy change and FDA spokesman Jack Martin said: “No decision has been made.”

But Dr. Sidney Wolfe, director of Ralph Nader’s Health Research Group, a consumer organization that first drew attention to the link between aspirin and Reye’s syndrome, said “there is 100% certainty there will be mandatory labeling. It’s a matter of when, not whether. But it should have been sooner.”

More stringent labeling legislation, sponsored by Rep. Henry A. Waxman (D-Los Angeles), is pending in the House. Waxman’s bill would require the warning to be highlighted graphically by a “box” and mandates that manufacturers place warning stickers on all bottles within 30 days of the law’s enactment.