FDA safety page: Drug errors associated with Maalox

January 8, 2007

Maalox is a well-recognized brand name that healthcare professionals associate with nonprescription or OTC antacid drug products containing the active ingredients aluminum hydroxide, magnesium hydroxide, and simethicone. However, the Food & Drug Administration wants to alert healthcare professionals that Maalox Total Stomach Relief (an OTC upset stomach reliever/antidiarrheal drug product) contains the active ingredient bismuth subsalicylate.

Following the introduction of Maalox Total Stomach Relief, the FDA was notified of several medication errors involving confusion between this product and the other currently marketed Maalox brands. The confusion stems from the limited awareness of the new formulation and its product differences. Additionally, the inclusion of labeling such as "New" and "Maximum Strength" used to describe Maalox Total Stomach Relief can be confusing. Maalox Total Stomach Relief is not a more potent formulation of the Maalox product labeled "Regular Strength" but actually contains a different active ingredient.

Here are some measures pharmacists can take in order to avoid confusion:

If you become aware of medication errors involving Maalox or other products, report them to the FDA MedWatch program online at http://www.fda.gov/medwatch.

Carol Holquist is Director and Todd Bridges is Safety Evaluator in the Division of Medication Errors and Technical Support, The Office of Surveillance and Epidemiology, at the FDA.