A Ralph Nader-founded health group charged yesterday that children continue to be "killed and injured" because of Food and Drug Administration delays in warning parents about a "strong link" between aspirin use and Reye syndrome.
Dr. Sidney Wolfe of the Health Research Group questioned the FDA's "lack of urgency" in responding to a series of government-sponsored studies showing that children with chicken pox or flu-like illnesses who are treated with aspirin appear to have an increased risk of contracting the life-threatening disease.
The group has petitioned the FDA to require that aspirin products be accompanied by warning labels and patient information, as well as prominently displayed signs in stores selling these products.
An FDA spokesman said yesterday that a task force there was at work on a review of the available medical evidence. "The reason it has taken the time that it has is that there is a considerable amount of data to be reviewed, but the review is being conducted expeditiously."
He said the review would be completed within a few weeks, adding that "Once we complete the review, then we will determine whether any regulatory action is necessary."
Reye syndrome is a mysterious ailment that sometimes follows viral illnesses, striking quickly, with vomiting and fever, and progressing to convulsions, coma and death in about 20 to 30 percent of the cases.
Wolfe yesterday sent a letter to Rep. John D. Dingell (D-Mich.), chairman of the Committee on Energy and Commerce, urging a congressional investigation of the matter.
Dingell issued a statement expressing concern about the lack of action, saying that the "public has a right to expect that public health problems will be handled with a speed that is responsive to the hazard."
He called it "intolerable" that the FDA has not decided whether to take action six months after a Centers for Disease Control advisory panel recommended that use of the drug should be avoided when possible for children with chicken pox or presumed cases of flu.
That recommendation was not made public until February, when the CDC issued a more cautious warning, which stopped short of endorsing the advisory panel recommendation. The CDC simply advised parents and physicians of the "possible increased risk," and left further regulatory action to the FDA.
Wolfe charged that the FDA had failed to act because of pressure from the aspirin industry. But the FDA spokesman said that all decisions had been made independently and "not on the basis of industry pressure."
Aspirin manufacturers have called the reported link between the commonly used drug and Reye syndrome "misleading and unjustified," saying that it is a "safe and highly effective medication for the reduction of fever in children."