Novartis to change name, repackage Maalox Total Relief

ROCKVILLE, Md. Choosing the wrong liquid Maalox product can have harmful consequences, the Food and Drug Administration warned consumers as part of a consumer update posted to its site Wednesday.

The FDA is concerned that consumers may be confused by the similar packaging and labeling of liquid Maalox and Maalox Total Relief. The two products are intended for the relief of different symptoms and contain different active ingredients, the agency noted.

Maalox Total Relief is an upset stomach reliever and antidiarrheal medication, while traditional Maalox liquid products Maalox Advanced Regular Strength and Maalox Advanced Maximum Strength are antacids.

Novartis Consumer Health 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 FDA stated in a separate press release.

“Maalox Total Relief and Maalox are not interchangeable and shouldn’t be used in place of each other,” state Carol Holquist, director of FDA’s division of Medication Error Prevention and Analysis. “Consumer confusion and incorrect product use due to name confusion are serious public health issues. We appreciate Novartis’ efforts to work collaboratively with FDA and their decision to remedy this situation to avoid any confusion over Maalox products in the future.”

Maalox Total Relief’s active ingredient (bismuth subsalicylate) is chemically related to aspirin and may cause similar harmful side effects such as bleeding. As such, Maalox Total Relief is not appropriate for individuals with a history of gastrointestinal ulcer disease or a bleeding disorder. Maalox Total Relief also should not be taken by children and teens if they are recovering from a viral infection, nor by individuals who are taking certain medications including: oral antidiabetic drugs (OADs), anticoagulation (thinning the blood) drugs such as warfarin (Coumadin) and clopidogrel (Plavix), non-steroidal anti-inflammatory drugs (NSAIDS), and other anti-inflammatory drugs.

The renamed product is expected to begin selling in September 2010. Until that time, FDA is advising consumers and healthcare professionals to carefully check the labels of all Maalox products to ensure the appropriate product is being selected for the patient’s symptoms.