FDA Issues Maalox Total Relief Warning

Consumers warned not to mistake Maalox Total Relief for Maalox antacid products
By Beth Gilbert
HealthDay Reporter

THURSDAY, Feb. 18 (HealthDay News) -- The U.S. Food and Drug Administration is warning consumers not to mistake Maalox Total Relief, a gastrointestinal and anti-diarrhea medication, for Maalox antacids (Maalox Advanced Regular Strength and Maalox Advanced Maximum Strength), as this could result in serious side effects.

Maalox Total Relief is packaged and labeled similarly to Maalox Advanced Regular Strength and Maalox Advanced Maximum Strength, which are available over the counter. The active ingredient in Maalox Total Relief, bismuth subsalicylate, is contraindicated in individuals with a history of gastrointestinal disease or bleeding disorder, and in those taking certain prescription medications such as blood thinners, anti-inflammatory drugs and oral antidiabetic drugs. In addition, adolescents and teens recovering from viral infections should not take Maalox Total Relief.

As of September, Novartis Consumer Health Inc., the manufacturers of these three products, will change the name of Maalox Total Relief, removing "Maalox" from the label and altering the packaging design. In addition to tracking any reported adverse reactions, the company will be launching an educational campaign, targeting both consumers and health care practitioners, to provide information regarding indications and safety of currently available Maalox products.

According to a Feb. 17 press release issued by the agency, "Maalox Total Relief and Maalox are not interchangeable and shouldn't be used in place of each other. Consumer confusion and incorrect product use due to name confusion are serious public health issues."

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