Diarrhea: Sweeping Changes in the OTC Market

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


US Pharmacist. 2005;30(1) 

In This Article

The Current Antidiarrheal Market

As of the date the 2003 document took effect, manufacturers were to have withdrawn or reformulated all products labeled for diarrhea that contained attapulgite, polycarbophil, calcium/polycarbophil, or the combination of kaolin and pectin. This leaves only two ingredients now proven safe and effective for diarrhea: bismuth subsalicylate and loperamide. Because of the 2003 FDA rule, bismuth subsalicylate cannot be safely dosed in self-care patients younger than 12 years. Further, the youngest age for which loperamide can be used in self-care situations is 6 years. Therefore, the pharmacist must now refer any patient with diarrhea who is younger than 6 years to a physician for care.

Kaopectate was originally a trade name for kaolin and pectin in combination; however, because of efficacy issues, the company changed the formula to attapulgite in the early 1990s. Thus, there were two product formulations on the market until stocks of the older kaolin/pectin bottles were depleted. There is evidence that requests for "Kaopectate" are still filled with kaolin and pectin in some government facilities (e.g., Federal Bureau of Prisons, U.S. Coast Guard Health Services).[4,5] Indeed, current formularies for these governmental facilities give the impression that kaolin and pectin are virtually synonymous with Kaopectate more than a decade after its reformulation.[4,5] During the kaolin/pectin and attapulgite periods, Kaopectate packages carried a prominent label indicating that they were a salicylate-free alternative to other antidiarrheals, such as those containing bismuth subsalicylate.

The situation changed in February 2003, when retail pharmacies began to receive new bottles of Kaopectate that contained bismuth subsalicylate. The bottles were labeled "New & Improved." Older bottles were not recalled, so two formulations existed simultaneously in bottles that appeared similar. A medication safety alert sent by the Institute of Safe Medication Practices warned pharmacists and other health care workers about the danger to patients who should not receive salicylates purchasing the salicylate formula.[6] MedWatch later reported that six medication errors involving the products had been logged. Four reporters stated that the sponsor did not adequately inform providers and patients of the reformlation.[7] As of late September 2004, company Web sites referred to the attapulgite formulas and suggested dosing for those as young as age 3, making it difficult for consumers to determine the correct dosage amid conflicting information.[8,9]


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