Over-the-counter antidiarrheal medications used for the self-treatment of acute nonspecific diarrhea

Abstract

Because there are approximately 100 over-the-counter (OTC) products available for self-treatment of acute diarrhea, it is difficult for consumers or even pharmacists and physicians to be sure which products are both safe and effective. Until Congress expanded the authority of the Food and Drug Administration in 1962, manufacturers only had to prove that their products were safe. Unfortunately, a majority of OTC products that are now available were on the market before 1962. To eliminate all noneffective products, the Food and Drug Administration established a three-phase OTC drug review process. The ultimate goal of this process is to ensure that all OTC medications are safe and effective and carry full and informative labeling. In 1975, the Advisory Review Panel on OTC Laxative, Antidiarrheal, Emetic, and Antiemetic Drug Products published its recommendations on which OTC antidiarrheal ingredients were both safe and effective [Antidiarrheal drug products for over-the-counter human use: proposed monograph. Federal Register 1975; 40: 12902–12944]. After consideration of these recommendations, public comment, and presented new evidence, the Food and Drug Administration published its preliminary safe and effective ingredient listing [Antidiarrheal drug products for over-the counter human use: tentative final monograph. Federal Register 1986; 51 (83): 16138–16149]. At this time, only three ingredients fulfill both requirements: attapulgite, polycarbophil, and loperamide. The Food and Drug Administration's final decision (to be reported in a monograph) is still forthcoming. Upon publication of this monograph, only antidiarrheal products that contain ingredients in this listing will be allowed to be marketed.