FDA Warns of Maalox Mix-up Danger

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Updated: 1/17/2013 7:20 pm

Feb. 17, 2010 - At least five "serious adverse events" occurred in people who took Maalox Total Relief thinking it was Maalox antacid, the FDA warns.

The two over-the-counter drugs are not the same. Maalox Total Relief contains bismuth subsalicylate, a drug with aspirin-like side effects that include stomach and intestinal bleeding. This drug should never be used by people with a history of 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 safely take Maalox Total Relief.

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.

The 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. However, the new label won't appear until September. Until then, Novartis has agreed to an outreach program that will warn consumers and medical professionals about the difference between the two product types.

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

Until the labels are changed, the FDA warns Maalox users to carefully read the product label. They should consult their pharmacist if they have any doubts about which product they should use.

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