Maalox Total Relief Name and Packaging Change

2/18/2010
As the result of an FDA warning, Novartis Consumer Health is changing the name and packaging for Maalox Total Relief (bismuth subsalicylate) to avoid confusion with other Maalox products due to the potential for serious side effects. Maalox Total Relief is an upset stomach reliever and antidiarrheal medication that is not interchangeable with the traditional liquid antacids Maalox Advanced Regular Strength and Maalox Advanced Maximum Strength. Maalox Total Relief’s active ingredient, bismuth subsalicylate, is chemically related to aspirin and may cause similar harmful side effects, such as bleeding. Maalox Total Relief should not be used by individuals with a history of gastrointestinal ulcer disease or bleeding disorder, children and teens recovering from a viral infection, or individuals who are taking certain medications, including oral antidiabetic drugs, anticoagulants (eg, warfarin [Coumadin] and clopidogrel [Plavix]), nonsteroidal anti-inflammatory drugs, and other anti-inflammatory drugs. Novartis expects to begin marketing the renamed product in September 2010. The FDA is advising consumers and health care professionals to carefully check the labels of all Maalox products to ensure that the appropriate product is being selected. Any adverse events that may be related to the use of any Maalox product should be reported to the FDA’s MedWatch Adverse Event Reporting program online, by returning the postage-paid FDA form 3500 by mail (to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787) or fax (1-800-FDA-0178).
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