Maalox product mix-ups spur name change.
Reports of mix-ups between Maalox products have prompted the manufacturer to change the name of one of the products, according to a notice posted on the Food and Drug Administration's MedWatch site.
The FDA has received five reports of consumers who used Maalox Total Relief, which contains bismuth subsalicylate, when they had intended to use one of the traditional Maalox antacid products, which contain aluminum hydroxide, magnesium hydroxide, and simethicone. Maalox products are manufactured by Novartis.
The Maalox antacid products have packaging similar to that of Maalox Total Relief, which is used to treat diarrhea, upset stomach associated with nausea, heartburn, and gas. Maalox Total Relief should not be used in certain populations, including children and teenagers recovering from a viral infection, and people on oral antidiabetic medications, anticoagulants, or NSAIDs, the statement said.
The FDA statement advised that when recommending a Maalox product to a patient, health care professionals should use the full name of the product or the name of the active ingredient.
Because of the "potential for serious adverse events" from confusing these products, the manufacturer has agreed to change the name of Maalox Total Relief to a name that does not include the word "Maalox," to change the graphics on the product's container, and to actively monitor and report adverse events. The manufacturer expects to start selling the renamed product in September 2010.
More information is available at www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafety InformationforPatientsandProviders/ucm199476.htm. The FDA is asking clinicians to report adverse events or medication errors involving these products to the MedWatch program at www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm.
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|Title Annotation:||CLINICAL ROUNDS|
|Publication:||OB GYN News|
|Article Type:||Brief article|
|Date:||May 1, 2010|
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