According to media reports, the warning results from five reports of serious medication errors involving consumers who used Maalox Total Relief, the upset stomach reliever and anti-diarrheal medication, by mistake, when they had intended to use one of the traditional Maalox liquid antacid products.
The FDA warning states: "Maalox Total Relief is an upset stomach reliever and anti-diarrheal medication, while traditional Maalox liquid products Maalox Advanced Regular Strength and Maalox Advanced Maximum Strength are antacids.
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. 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" and will change the drug's packaging to avoid further confusion.
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.
The renamed product is expected to begin selling in September 2010."