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Is That Right? Maalox Total Relief ingredient is safe?

The U.S. Food and Drug Administration this week issued a safety announcement that cautioned consumers to be careful when choosing which Maalox product to use. The boxes and product names are similar, but the contents in some cases are very different.

The FDA noted five instances of "serious medication errors" among people who mistakenly took Maalox Total Relief instead of a different liquid Maalox product. Whereas most Maaloxes are simple antacids, the Total Relief variety is an upset-stomach reliever and anti-diarrheal that contains bismuth subsalicylate, an aspirin-related ingredient that can foster stomach bleeding in people with gastrointestinal ulcers, bleeding disorders and a variety of other conditions.

The agency said that Novartis, which makes the Maalox family of products, has agreed to change product names and packaging to make it easier for consumers to figure out which one best matches their symptoms. Those changes aren't expected to take effect until September.

Here's an excerpt from the FDA notice:

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's Web site addresses the issue in a section about "the appropriate use of Maalox Total Relief" but doesn't directly address the potential harm Total Relief might cause. Instead, it notes that bismuth subsalicylate is safe and effective when used as directed.

The Maalox site also offers this symptom checker, which matches your ills to the right product. But it's kind of simplistic, and it doesn't help someone standing in the pharmacy aisle trying to sort through the box labels.

Here's an excerpt from the Maalox site:

Maalox Total Relief contains bismuth subsalicylate, a safe and effective ingredient for the relief of upset stomach associated with nausea, heartburn, and gas due to overindulgence in food, and for the relief of diarrhea. For more than 90 years, Americans have used this ingredient safely and effectively in many over-the-counter products.
Maalox Advanced regular strength liquid and Maalox Advanced maximum strength liquid products contain different active ingredients than Maalox Total Relief and are intended for different uses.
Maalox Advanced liquid products contain the antacid ingredients aluminum hydroxide and magnesium hydroxide for the relief of acid indigestion, sour stomach, heartburn and upset stomach due to these symptoms, and the anti-gas ingredient simethicone for pressure, bloating and fullness commonly referred to as gas.
Maalox Total Relief and Maalox Advanced liquid products are not interchangeable. People should always read the complete drug facts label on all over-the-counter products before use and should only use medicines that treat their specific symptoms.

Well, of course we should. But what if my specific symptom is, say, gas? Or heartburn? Both products treat both. And how am I supposed to know whether my upset stomach stems from overindulgence in food or from acid indigestion?

Bismuth subsalicylate may well have a long and safe track record. But the FDA's right: Maalox's packaging needs an overhaul.

By Jennifer LaRue Huget  |  February 19, 2010; 7:00 AM ET
Categories:  Is That Right?  
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This is the problem with multi-symptom OTC drugs - you usually end up taking medicine you don't need or want. If you have nausea and diarrhea (especially if you suspect it is due to bacteria) take Pepto (bismuth subsalicylate); if you have acid indigestion, take an antacid; if you have gas, take a simethicone-based anti-gas preparation (although the research on whether they really work doesn't seem to support using them).

If you are getting these symptoms from overeating, stop overeating (not a popular remedy).

Unfortunately, people shopping for OTC drugs tend to think "more is better" and choose multi-symptom drugs over the cheaper (and often generic) single drugs. Some drugs, such as Pepto, should not be taken without a good reason - the inclusion of bismuth subsalicylate in Maalox (which a lot of folks take daily) is not a good idea. Unfortunately, even a packaging overhaul will probably not combat the "more is better" mentality.

Posted by: drmary | February 20, 2010 2:56 PM | Report abuse

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