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FDA Warns Consumers of Possible Side Effects Related to Confusing Maalox Labels

March 1, 2010

On February 17, 2010, the U.S. Food and Drug Administration (FDA) warned consumers about the potential for serious side effects by mistakenly taking Maalox® Total Relief instead of other Maalox® products. The products, made by Novartis Consumer Health Inc., are generally intended to help relieve heartburn and acid indigestion, but have significantly different active ingredients.

Both products are over-the-counter medications available without a prescription. The source of the risk lies in bismuth subsalicylate, the active ingredient in Maalox® Total Relief. According to the FDA release, this ingredient is “chemically related” to aspirin and may cause similar harmful side effects, such as bleeding. As a result, the agency warns that Maalox® Total Relief is not appropriate for individuals with a bleeding disorder or a history of gastrointestinal ulcer disease. 

Maalox® Total Relief and Maalox are not interchangeable and shouldn’t be used in place of each other,” says Carol Holquist, RPh, director of FDA’s Division of Medication Error Prevention and Analysis. “Consumer confusion and incorrect product use due to name confusion are serious public health issues. We appreciate Novartis’ efforts to work collaboratively with FDA and their decision to remedy this situation to avoid any confusion over Maalox® products in the future.”

The FDA also advises the following groups against using Maalox® Total Relief : children/teens recovering from a viral infection and individuals who are taking certain medications including: oral antidiabetic drugs (OADs), anticoagulation (blood thinners) drugs such as warfarin (Coumadin) and clopidogrel (Plavix), nonsteroidal anti-inflammatory drugs (NSAIDS) and other anti-inflammatory drugs.

Novartis Consumer Health Inc. has agreed to change the product brand name of Maalox® Total Relief to one that does not include the word “Maalox.” It will also change the drug’s packaging to avoid further confusion. The renamed product will be in stores in September 2010. Until then, FDA recommends that both consumers and healthcare professionals carefully check all Maalox® product labels to make certain that the right product is chosen for the patient’s symptoms.

Read the entire FDA release

Source: FDA news release dated February 17, 2010