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Bills Introduced To Require Warnings On Aspirin

February 28, 1985

WASHINGTON (AP) _ Bills were introduced in Congress on Thursday to require aspirin to carry label warnings that the product is sometimes associated with deadly Reye’s Syndrome when taken by children.

Sen. Howard M. Metzenbaum, D-Ohio, and Rep. Henry A. Waxman, D-Calif., said they were introducing the bills on an emergency basis, hoping to get the warning labels in place before the end of the current flu season.

Studies have indicated that Reye’s Syndrome can occur in children and young adults who take aspirin while suffering from the flu or chicken pox.

The Department of Health and Human Services has sought voluntary action by aspirin makers to place warnings on their labels and on posters in stores where aspirin is sold, but Metzenbaum and Waxman said this is not sufficient.

The voluntary apporoach is ″quite inadequate,″ said Waxman, commenting that evidence of the relationship between Reye’s and aspirin has been building for three years.

″I don’t think the Congress can sit by and see another flu season go by....″ he said.

He added that the labels planned to be used by industry only caution parents to check with a physician before giving aspirin to children, they do not mention Reye’s Syndrome.

A check of stores in the Washington area showed that many did not have the voluntary warning posters, Metzenbaum said.

Besides, he said, because a parent seeking something to help a sick child is unlikely to take time to read a sign in a store, the warning needs to be on the bottle.

Dr. Sidney M. Wolfe of the Public Citizen Health Research Group supported the legislation, estimating that there have been more than 600 cases of Reye’s Syndrome since 1982 including 175 deaths.

″This (aspirin) is an over-the-counter drug that is most often used without a physician being involved, and in such cases labeling is very important,″ Wolfe said.

The Metzenbaum-Waxman bill would give manufacturers 30 days to change their labels or add warning stickers stating that aspirin should not be used by persons under age 21 who have chicken pox or flu symptoms.

Dr. Joel Taubin of Potomac, Md., whose 11-year-old son Gregory died of Reye’s in 1979, also spoke in support of the bills, commenting that ″it’s the most terrible thing in the world to have a healthy child die, within hours or days, from a preventable disease.″

Taubin is vice president of the National Reye’s Syndrome Foundation, an association of people interested in spreading warnings about this disease.

Bruce Dickson, counsel of the Aspirin Foundation of America, responded that early studies associating Reye’s with aspirin were poorly done and said current research remains incomplete.

Many manufacturers are planning some label warnings as a precaution, he said, as well as sending out broadcast public service announcements and other warnings.

″We feel that these are really enough at this point. We feel that the full study ought to be done ... we have not yet proven anything,″ Dickson said.

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