Practitioners' Reporting News

Kaopectate® Reformulated

Issued June 3, 2003

Three recent reports were submitted to the USP Medication Errors Reporting Program regarding Pharmacia's (recently acquired by Pfizer) over-the-counter product Kaopectate® New & Improved. The new formulation contains bismuth subsalicylate. The previous formulation contained attapulgite as the active ingredient, while even earlier formulations contained kaolin and pectin (hence the brand name Kaopectate). Each reformulation has retained the original trade name.

The reporters expressed concern that the new formulation could unknowingly result in an overdose of salicylates, or be given to children and pose a risk for the development of Reye's Syndrome. Reye's Syndrome is a rare, acute, and sometimes fatal disease, occurring mainly in children and usually following viral infection. The disease affects mainly the liver and the brain.

In the first report, a community pharmacist received a prescription to make a compound containing Kaopectate. The pharmacist pulled Kaopectate from the shelf and noticed it read "New & Improved." After realizing Kaopectate no longer contained attapulgite, the pharmacist contacted the wholesaler that sent the new formulation in place of the old formulation. According to the reporter, the same trade name and National Drug Code number is being used on the labeling of two different formulations.

In a second report, a pharmacy student informed his professor of the new formulation. The professor considered the labeling inadequate to convey to the consumer that the product now contains a salicylate. In a similar report, another professor indicated that the peel-off label tore when trying to access the new warnings.

Picture of Kaopectate New & Improved labeling (provided by reporter)

Picture of Kaopectate New & Improved labeling—peel-off label (provided by reporter)

According to the National Reye's Syndrome Foundation (NRSF), Inc., research has shown an association between Reye's Syndrome and the use of aspirin (a salicylate compound) for treating the symptoms of viral illnesses. Although other forms of salicylates have not been conclusively associated with Reye's Syndrome, the NRSF recommends that any products containing salicylates not be taken during episodes of viral infections until further research is completed.

While the new formulation of Kaopectate continues to be introduced, it is important that healthcare professionals counsel parents about the new formulation and take precautions to help prevent salicylate overdose and adverse events in children. This is especially important because Kaopectate is available over-the-counter, where consumers may be less aware of changes in formulations.

Readers are advised that official USP cautions and warnings for drugs appear in the USP–NF or USP DI. Unless otherwise indicated, any advice or opinions expressed herein reflect solely the judgment of USP staff. Such statements are intended for further consideration and evaluation and may or may not be applicable to a particular practice. The USP Medication Errors Reporting Program is presented in cooperation with the Institute for Safe Medication Practices.