Neurologist

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Drug Information Update – FDA Drug Safety Communication: Product Confusion with Maalox Total Relief and Maalox Liquid Products

FDA/CDER/Division of Drug Information (DDI)

The Division of Drug Information (DDI) is CDER’s focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation byFDA.


 

The U.S. Food and Drug Administration (FDA) has received 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.

Due to the potential for serious adverse events from product confusion, the maker of Maalox brand products has agreed to:

  • Change the name of Maalox Total Relief to one that will not include the name “Maalox” and revise the graphics and information displayed on the front of the product container to help distinguish the active ingredients and uses of this product from the traditional Maalox antacids. 
  • An educational program that includes outreach to healthcare professionals and consumers to inform them about the different products sold under the Maalox brand, including how to select the appropriate Maalox brand product. 
  • Active safety monitoring and reporting of adverse events associated with the use of Maalox brand products.

For more information, please visit: Maalox

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February 19, 2010 - Posted by | 1

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