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FDA warning for Maalox Total Stomach Relief

PTINR.com Staff

New product offering poses a risk for patients taking Coumadin (R)

The U.S. Food and Drug Administration’s (FDA) Division of Medication Errors and Technical Support issued a warning about serious side effect concerns and confusion over a new Novartis Consumer Health Maalox®* product introduction. The warning has been issued to healthcare professionals and patients. The Novartis product Maalox® Total Stomach Relief has resulted in several medication errors and poses a risk for patients taking anticoagulants including Coumadin®**.1

If you are taking Coumadin®, you are advised not to use the product Maalox® Total Stomach Relief due to an increased risk of bleeding.2 The company is planning to change the name of the product without the name Maalox®. The new name and packaging is scheduled to be available in September 2010.1

Working closely with the FDA, Novartis Consumer Health has agreed to:

  • Change the product name so Maalox® is not part of the root name
  • An educational campaign to help healthcare professionals and consumers differentiate between Maalox® products
  • Actively monitor and report adverse events1

Maalox® Total Stomach Relief is not stronger than any of their other products. Unlike other Maalox® products, Maalox® Total Stomach Relief contains the active ingredient bismuth subsalicylate – a product known to cause drug-to-drug and drug-to-disease interactions. Several drug-to-drug interactions include Coumadin®, hypoglycemic agents, and nonsteroidal anti-inflammatory drugs (NSAIDS). Medical conditions affected by the active ingredient in Maalox® Total Stomach Relief include gout, stomach ulcers, kidney disease, and bleeding problems.1 Patients consuming products containing salicylates may experience an increase in their INR test results.2

The FDA stated although there is a warning label on the bottle – "it is not prominent and could easily be overlooked." The Maalox® product line uses similar shaped and size bottles with the familiar Maalox® font type and orientation, prompting the government to urge doctors, pharmacists and patients to read the drug facts on the packaging.1

Recommendations for patients

The FDA’s recommendation is for patients to read the label before they buy any products. Confusion may remain as the name of product ingredients can be as difficult to pronounce as it is to understand how or if it will interact with Coumadin®.

Recommendations from the FDA include:

  • Asking your pharmacist before you purchase a Maalox® product
  • Share with your pharmacist that you are taking Coumadin®
  • Physically separate different formulations to minimize confusion1

*Maalox® is a trademark of Novartis Consumer Health Canada Inc. **Coumadin® is a registered trademark of Bristol-Myers Squibb Pharma Company.

1 Holquist, C., 2007. Drug errors associated with Maalox. Drug Topics
2 FDA Drug Safety Communication: Product Confusion with Maalox Total Relief and Maalox Liquid Products http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafety
InformationforPatientsandProviders/ucm199476.htm. Page Last Updated: 02/19/2010.
3 Bristol-Myers Squibb Company. (2009). Medication Guide for Coumadin Tablets and Coumadin for Injection [Package Insert]. Princeton, NJ: Bristol-Myers Squibb Company.

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