Why was maalox taken off the market

But Novartis says it has no plans to change the labelling of Maalox Multi-Action in Canada, even though the product also contains bismuth subsalicylate. The new labelling in the U. Until then, Novartis has agreed to a public education program to warn consumers and doctors about the difference between the two products.

Meanwhile, the FDA is warning manufacturers not to market products that have different active ingredients yet similar labelling. To help avoid the potentially serious health risks from Maalox product mix-ups, the FDA recommends that consumers:. Carefully look at the labels of all Maalox products to make sure the right product is being purchased for the right condition. Read the active ingredients, uses and warnings on the package prior to purchasing.

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Maalox Total Relief is not appropriate for individuals who want to use an antacid, especially if they have a history of gastrointestinal ulcer disease or a bleeding disorder. Maalox Total Relief contains the active ingredient bismuth subsalicylate and is used to treat diarrhea, upset stomach associated with nausea, heartburn, and gas due to overindulgence in food overeating.

Bismuth subsalicylate is chemically related to aspirin and may cause similar adverse effects such as bleeding. Bismuth subsalicylate has a warning statement stating that it should not be used in people who have or have a history of gastrointestinal ulcers or a bleeding disorder.

Maalox Total Relief should not be used in children and teenagers if they are recovering from a viral infection. The product should also not be used in people who are taking oral anti-diabetic medications, blood thinning medications such as Coumadin warfarin or Plavix clopidogrel , and non-steroidal anti-inflammatory drugs NSAIDS like ibuprofen and naproxen.

The traditional Maalox liquid products including Maalox Advanced Regular Strength and Maalox Advanced Maximum Strength are well-recognized antacid drug products that contain aluminum hydroxide, magnesium hydroxide, and simethicone. Mistaking Maalox Total Relief for one of the antacid products could lead to serious side effects.

Five cases of serious side effects in people who mistook Maalox Total Relief for one of the antacid products have been reported to the FDA. The agency did not provide the details about the five cases, but a fix is on the way. And that goes for all drugs, not just these Maalox products. This means it should not be taken by people with a history of gastrointestinal ulcer disease or a bleeding disorder. A final concern is that Maalox Total Relief could interact with other medications, including oral diabetes drugs, blood-thinners, such as warfarin Coumadin and generic and clopidlogrel Plavix , and non-steroidal anti-inflammatory drugs, such as naproxen Aleve and generic or ibuprofen Advil and generic.