February 18, 2010
FDA warns of Maalox Total Relief medication errorsThe FDA and Novartis Consumer Health have notified healthcare professionals about reports of serious medication errors involving patients who used Maalox Total Relief (bismuth subsalicylate) when they had intended to use a Maalox liquid antacid. Maalox Total Relief is indicated as an anti-diarrheal and for the relief of upset stomach. Maalox Advanced Regular Strength (aluminum hydroxide/magnesium hydroxide) and Maalox Advanced Maximum Strength liquids (aluminum hydroxide/magnesium hydroxide/simethicone) are antacids indicated for heartburn, acid indigestion, sour stomach, and upset stomach.
Maalox Total Relief should not be used in people who have or have a history of gastrointestinal ulcers or a bleeding disorder. It also should not be taken by children recovering from a viral infection, nor by individuals taking certain medications (eg, oral antidiabetic drugs, anticoagulants, clopidogrel, non-steroidal anti-inflammatory drugs, and other anti-inflammatory drugs).
Novartis has agreed to change the name of Maalox Total Relief to one that will not include the name “Maalox.” The renamed product is expected to be made available in September 2010. Until that time, healthcare professionals and patients should be aware that Maalox Total Relief and traditional Maalox products are not interchangeable and are intended to treat different medical conditions.
For more information visit www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm199476.htm.