Maalox Multi Action (bismuth subsalicylate) - Confusion with Other Maalox Liquid Products - For the Public

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Contact: Marketed Health Products Directorate

The Health Products and Food Branch (HPFB) posts on the Health Canada Web site safety alerts, public health advisories, press releases and other notices as a service to health professionals, consumers, and other interested parties. These advisories may be prepared with Directorates in the HPFB which includes pre-market and post-market areas as well as market authorization holders and other stakeholders. Although the HPFB grants market authorizations or licenses for therapeutic products, we do not endorse either the product or the company. Any questions regarding product information should be discussed with your health professional.

This is duplicated text of a letter from Novartis Consumer Health Canada Inc.
Contact the company for a copy of any references, attachments or enclosures.

Public communication
Health Canada Endorsed Important Safety Information on Maalox Multi Action (bismuth subsalicylate)

May 17, 2010

Subject: Maalox Multi Action (bismuth subsalicylate) and confusion with other Maalox liquid products

Novartis Consumer Health Canada Inc., in consultation with Health Canada, would like to bring to your attention important safety information about the differences between our product Maalox Multi Action and other Maalox liquid products.  It is important to know that Maalox Multi Action and other Maalox liquid products have similar names, labels and packaging, but contain very different ingredients.

Maalox Multi Action contains bismuth subsalicylate, which is related to acetylsalicylic acid (ASA). The unintentional use of bismuth subsalicylate by some people taking certain medicines or who have certain health conditions, could cause serious side effects. For example, people taking medicine for thinning the blood have an increased risk of bleeding if taking Maalox Multi Action.

There have been Canadian reports of serious adverse events that have been reported in patients using Maalox Multi Action instead of other Maalox liquid products. 

Maalox Multi Action contains bismuth subsalicylate. It is used to relieve upset stomach and diarrhea. All other Maaloxliquid products are used as antacids and contain aluminum or magnesium hydroxide, calcium or magnesium carbonate, plus simethicone for relief of gas or sodium alginate for relief of acid reflux.

When selecting a Maalox liquid product, consumers should read product labels carefully, including warnings, to ensure that they choose the appropriate Maalox liquid product for their specific condition.

Ask your doctor or pharmacist for help if you are unsure.

Novartis Consumer Health Canada Inc. is working with Health Canada to change the name, label and packaging of Maalox Multi Action to make the product differences more easily understood.

Managing marketed health product-related adverse reactions depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing adverse reactions are generally presumed to underestimate the risks associated with health product treatments. Any case of serious or unexpected adverse reactions in patients receiving any Maalox liquid product should be reported to Novartis Consumer Health Canada Inc. or Health Canada at the following addresses:

Should you have any questions regarding the use of Maalox Multi Action or any other Maalox liquid product, please contact Novartis Consumer Health Canada Inc. at the address or telephone number listed above.