FDA Warns of Maalox Mix-up

By Frank E. Goldman, PharmD.

Reading medication labels carefully is important. It is easy to be confused or fooled by products with similar names that target different conditions.

At least five "serious adverse events" occurred in people who took Maalox Total Relief thinking it was Maalox antacid.

The two over-the-counter drugs are not the same. Maalox Total Relief contains bismuth subsalicylate, a drug with aspirin -and can have side effects that include stomach and intestinal bleeding. This drug should never be used by people with a history gastrointestinal ulcers or bleeding disorders.

Maalox Advanced Regular Strength and Maalox Advanced Maximum Strength contain antacid and anti-gas ingredients. People who are able to take regular Maalox may not be able to take Maalox Total Relief safely.

The drugs have different indications:       

• Maalox Total Relief is for diarrhea, upset stomach associated with nausea, heartburn, and gas due to overeating.
• Maalox Antacids are for acid indigestion, heartburn, sour stomach, upset stomach, and gas.

These drugs are not interchangeable. Yet the two products have similar labels that feature the Maalox brand name--- a name many consumers associate with the antacid.

Novartis, which makes the Maalox products, has agreed to drop the name Maalox from the label of Maalox Total Relief. The new label, however, won't appear until September.

Novartis also will conduct active safety monitoring and reporting of adverse events associated with Maalox brand products.

Until the labels are changed, the Federal Drug Administration warns Maalox users to read the product label carefully.

Posted March 2010
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Have a question about medication? Reach  Dr. Goldman  during business hours by calling 410 968-1200 (X-3490) .