Diarrhea: Sweeping Changes in the OTC Market

W. Steven Pray, PhD, DPh; Joshua J. Pray, PharmD candidate

Disclosures

US Pharmacist. 2005;30(1) 

In This Article

Oral Rehydration Solutions

Developed in the 1960s and 1970s, oral replacement therapy (ORT) has succeeded in drastically reducing mortality in infants and children worldwide.[10,11] In 1978, five million children younger than 5 years died of acute diarrhea.[10] ORT packets were widely distributed to developing countries in the 1970s. This effort was followed by a steady decline in mortality. Only 4.6 million children died in 1980, 3.3 million in 1990, 1.5 million in 2000, and 1.3 million in 2002.[10] ORT replaces lost fluid, which avoids intravenous replacement in over 80% of mild to moderate cases and, more importantly, saves lives in acute cases of diarrhea.

ORT is regularly used to treat cholera-induced diarrhea, travelers' diarrhea, and rotavirus-induced diarrhea. Rotaviral diarrhea is most prevalent in developed countries; in developing countries, it accounts for 20% to 25% of infant deaths.[10]

ORT therapy should be individualized to different types of diarrhea, which involve varying fecal sodium concentrations. Since the inception of ORT, many different solutions have been produced that vary in concentrations of electrolytes and energy substrates. The World Health Organization (WHO) has recommended a solution containing (per liter) 3.5 g sodium chloride, 2.5 g sodium bicarbonate, and 1.5 g potassium chloride. This supplies 90 mM/L of sodium, which is sufficient for cholera but can cause hypernatremia in cases of rotaviral diarrhea.[10] (Fecal sodium concentrations in cholera range around 90 mM/L, while concentrations of sodium in the feces generally tend to be only 45 mM/L in rotaviral diarrhea.) WHO now recommends a solution with an intermediate amount of sodium at only 75 mM/L.[10,12,13] A rice-based solution containing 50 g of cooked rice powder is also available. This solution is hypoosmolar when compared to WHO's standard ORT and replaces the 111 mM/L of glucose with powdered rice. Rice-based ORT accounts for a 32% to 35% decrease in fluid requirements compared to standard ORT.[11] Despite research confirming their efficacy, the status of ORT has been murky, since they were not addressed by the FDA in the antidiarrheal monographs. In 2003, the agency clarified their status as OTC products, stating that they are regulated as foods under the Food Drug and Cosmetic Act.[14]

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