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Executive Summary

AMA MULTIVITAMIN PARENTERAL GUIDELINES SHOULD BE MODIFIED to require higher doses of vitamins B1, B6 C and folate in the adult preparations, a joint American Medical Association (AMA)/FDA panel concluded Aug. 21. The panel met to reassess the AMA's guidelines for multivitamin preparations for parenteral use, published in 1975 and adopted by FDA in 1979, in light of the results of studies by USV, Roche and Abbott. FDA had approved the firms' multivitamin preparations with the understanding that postmarketing studies would be conducted to test the dose that was recommended by the AMA. Upon reviewing the three firms' studies and other currently available information, the panel concluded that the guidelines should be revised to raise, for adults, the amounts of folate from 400 ug to 600 ug, vitamin B1 from 3 mg to 6 mg, vitamin B6 from 4 mg to 6 mg, and vitamin C from 100 mg to 200 mg. Studies indicated, the panel agreed, that adults on Total Parenteral Nutrition (TPN) formulated according to the 1975 guidelines were in the "low normal range" for those four vitamins. The panel also agreed to consider adding, at a later time, vitamin K to the suggested composition for adult I.V. multivitamin formulations. The possible addition of vitamin K to the formulation guidelines will be discussed at a later meeting when more information on possible problems and recommmended dose is available, the panel concluded. Citing the varied testing procedures of vitamin availability in TPN patients, the panel recommended that FDA outline uniform procedures for I.V. multivitamin protocols. Panel member Maurice Shils, MD, Memorial Sloan-Kettering Cancer Center, suggested that with regard to future studies there should be "standardization of the total amount of time on the test dose, standardization on the duration of infusion, standardization of the time of adding the vitamins to the infusion ]and[ standardization of the time of sampling after termination of infusion of vitamins." The panel agreed that the specifics of the protocols would have to be decided at a future meeting. With regard to the suggested composition of the pediatric formulation, the panel agreed that there is no evidence to warrant a change from the 1975 guidelines. However, the panel agreed with a recommendation by Harry Greene, MD, Vanderbilt University Medical Center, to "convene a special group of interested parties to review the data that is available for premature infants and to make recommendations based on current knowledge about the needs and requirements of this special group of infants as far as vitamin and nutrient intakes."

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