FDA Issues Warning of Problems from Mixup of Maalox Products

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Maalox products are best known as antacids. Indeed, the company’s traditional products -- Maalox Advanced Regular Strength and Maalox Advanced Maximum Strength -- are antacids.

There is another Maalox product which is not an antacid. That product is Maalox Total Relief. It is an upset stomach reliever and anti-diarrheal medication.

The U.S. Food and Drug Administration (FDA) is warning consumers about the potential for serious side effects from mistakenly using Maalox Total Relief instead of other Maalox products. The two products are intended for the relief of different symptoms and contain different active ingredients.

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Both Maalox Total Relief and Maalox are made by Novartis Consumer Health Inc. (NCH) and are available without a prescription as over-the-counter liquid medications. Packaging and labeling of Maalox Total Relief and traditional Maalox Advanced Regular Strength and Maalox Advanced Maximum Strength are very similar and easily confused.

The maker of Maalox brand products has agreed to change the name of Maalox Total Relief to one that does not include the word “Maalox.” The drug’s packaging will also be changed to avoid further confusion.

The renamed product is expected to begin selling in September 2010. Until that time, FDA is advising consumers and healthcare professionals to carefully check the labels of all Maalox products to ensure the appropriate product is being selected for the patient’s symptoms.

Maalox Total Relief
’s active ingredient (bismuth subsalicylate) is chemically related to aspirin and may cause similar harmful side effects such as bleeding. As such, Maalox Total Relief is not appropriate for individuals with a history of gastrointestinal ulcer disease or a bleeding disorder. Maalox Total Relief also should not be taken by children and teens if they are recovering from a viral infection, nor by individuals who are taking certain medications including: oral antidiabetic drugs (OADs), anticoagulation (thinning the blood) drugs such as warfarin (Coumadin) and clopidogrel (Plavix), non-steroidal anti-inflammatory drugs (NSAIDS), and other anti-inflammatory drugs.

Any Maalox side effects or other product problems should be reported to FDA’s MedWatch Adverse Event Reporting program at www.fda.gov/MedWatch or by calling 1-800-332-1088.

For further information:
FDA Drug Safety Communication: Product Confusion with Maalox Total Relief and Maalox Liquid Products

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