REYE's SYNDROME/ASPIRIN WARNING USE BY PRIVATE RETAILERS

Executive Summary

REYE's SYNDROME/ASPIRIN WARNING USE BY PRIVATE RETAILERS is being urged by FDA through letters mailed Aug. 23. In the letter, FDA Com. Young asks retailers of private label aspirin products to join larger aspirin mfrs. to "voluntarily amend your labels and labeling as proposed by the Aspirin Foundation for aspirin and aspirin-containing products" to warn of the possible association with Reye's Syndrome. Young requested the retailers and distributors to "remove from products packaged only for use in children (pediatric products) indication for use in 'flu' " and to add to the labels of all such products the statement: "Warning: Contact a physician before giving this medicine to children, including teenagers, with chicken pox or flu." Retailers and distributors of private label aspirin products are also requested to notify FDA of the actions they take to inform customers about Reye's Syndrome and the use of aspirin products. The commissioner requested retailers to use point-of-sale notices to advise parents and teenagers of Reye's Syndrome. Included with the letter is a copy of the American Reye's syndrome Association/Reye's Syndrome Society/National Reye's Syndrome Foundation poster for use as a point-of-sale warning of Reye's Syndrome. The poster was mailed out to pharmacists Aug. 1 and Sept. 1 and was included as a tearout in the September issue of American Druggist ("The Pink Sheet" Aug. 12, T&G-4).