AMERICANACADEMYOFPEDIATRICS.PDFVIP

AMERICAN ACADEMY OF PEDIATRICS Committee on Drugs “Inactive” Ingredients in Pharmaceutical Products: Update (Subject Review) ABSTRACT. Because of an increasing number of re- bronchospasm from antiasthmatic drugs, aspartame- ports of adverse reactions associated with pharmaceutical induced headache and seizures, saccharin-induced excipients, in 1985 the Committee on Drugs issued a cross-sensitivity reactions in children with sulfon- position statement1 recommending that the Food and amide allergy, benzyl alcohol toxicity in neonates Drug Administration mandate labeling of over-the- receiving high-dose continuous infusion with pre- counter and prescription formulations to include a qual- served medications, dye-related cross-reactions in itative list of inactive ingredients. However, labeling of inactive ingredients remains voluntary. Adverse reac- children with aspirin intolerance, lactose-induced di- tions continue to be reported, although some are no arrhea, and propylene glycol-induced hyperosmola- longer considered clinically significant, and other new lity and lactic acidosis. Although many other excipi- reactions have emerged. The original statement, there- ents have been implicated in causing adverse fore, has been updated and its information expanded. reactions, these are the most significant in the pedi- atric population. ABBREVIATIONS. FDA, Food and Drug Administration; MDIs, ANTIASTHMATIC MEDICATIONS metered-dose inhalers