ST LOUIS (MD Consult) - On February 17, 2010, the US Food and Drug Administration (FDA) issued a warning about the potential for the occurrence of serious adverse effects if the product Maalox Total Relief is mistakenly taken instead of other Maalox products. The products are not interchangeable.
Maalox Total Relief, which contains bismuth subsalicylate, is used for the treatment of stomach upset and diarrhea, whereas the traditional Maalox liquid products Maalox Advanced Regular Strength and Maalox Advanced Maximum Strength are considered antacids. Bismuth subsalicylate is chemically related to aspirin and may cause similar harmful adverse effects (eg, bleeding).
Persons with bleeding disorders and persons with a history of gastrointestinal ulcers should not ingest Maalox Total Relief. The medication also should not be given to children and teenagers during recovery from viral infections, nor to persons who are being treated with certain medications including oral antidiabetic agents, anticoagulants (eg, warfarin and clopidogrel), and anti-inflammatory drugs.
The 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" and will change the drug's packaging to avoid further confusion. The renamed product is expected to begin selling in September 2010. Until that time, the FDA is advising consumers and health care professionals to carefully check the labels of all Maalox products to ensure appropriate product selection.