Aspirin Firms Agree to Use Warning Labels
The aspirin industry, bowing to intense pressure to alert the public about the association between aspirin use in children and the often-fatal Reye’s Syndrome, agreed in a closed meeting Friday to voluntarily put warning labels on aspirin products.
Representatives from major aspirin manufacturers met late Friday with Dr. Mark Novitch, deputy food and drug commissioner, and agreed to develop labeling that would warn against giving aspirin to children and teen-agers suffering from chicken pox or flu.
“We told them that our organization was interested in working with them to develop labeling for aspirin products in reply to the request of the secretary of health and human services,” said Joseph White, president of the Aspirin Foundation of America, who attended the meeting.
White said he did not know how long it would take for the new labels to be placed on aspirin containers. Government and industry officials plan to meet again next week, he said.
The action, which came after several years of resistance by aspirin manufacturers, followed a plea earlier this week from Health and Human Services Secretary Margaret M. Heckler that they take immediate steps to label their products.
Her request was prompted by the release of an unpublished pilot study conducted by the federal Centers for Disease Control that found that children and teen-agers suffering from flu or chicken pox were 12 to 25 times more likely to develop Reye’s Syndrome when given aspirin than sick children who did not take the drug.
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.
Until just before the meeting, all but one aspirin manufacturer had delayed responding to Heckler’s request, calling the release of the pilot study “premature” and asking for more time to study the data. In a statement issued before the meeting, White had said that his group--which represents major aspirin manufacturers--was seeking a full review of the pilot study, although “we are also discussing the matter with the FDA in a spirit of cooperation.”
But the National Academy of Sciences’ Institute of Medicine called the pilot study sound and recommended “that steps should be taken to protect the public health, before the full study is completed.”
Dr. Harry Jennison, executive director of the American Academy of Pediatrics, said in an interview Friday that the latest evidence is “statistically significant beyond any shadow of doubt” and “clearly demonstrates the relationship of aspirin to the occurrence of Reye’s in the situation of influenza and chicken pox.” Although he did not call for specific product labeling, he said: “There is now a duty to warn.”
California Rep. Henry A. Waxman (D-Los Angeles), chairman of the House Energy and Commerce subcommittee on health and the environment, had predicted Friday that Congress would act if aspirin manufacturers failed to do so.
In a letter to Heckler, he asked that the secretary provide his subcommittee with a progress report by March 15, saying: “Since we are currently in the influenza season, it is of the utmost urgency that the public be warned against the use of aspirin in cases of chicken pox and influenza.”
Initially, only Plough Inc., a Memphis, Tenn., drug company-- which is not a member of the Aspirin Foundation--agreed to Heckler’s request. The company said it would take “all reasonable steps” to comply, although it still believed that there was no evidence that aspirin contributes to the onset of Reye’s Syndrome.
Neil Chayet, a spokesman for the Committee for the Care of Children, an organization originally funded by the aspirin industry, criticized Heckler’s proposal, saying that “more damage is done to this country by precipitous warnings and panicking people to death than warnings based on appropriate science.”
The debate on the association between Reye’s Syndrome and aspirin had been raging for several years. According to the Health Research Group, a consumer organization that released the CDC study earlier this week, 153 children have died of Reye’s Syndrome since 1982 out of 556 reported cases. In June, 1982, HHS announced that it would require labels on aspirin warning against its use for childhood diseases, but withdrew the proposal after the drug industry lobbied heavily against it.
