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Maalox Multi Action (bismuth subsalicylate) - Confusion with Other Maalox Liquid Products - For Health Professionals
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(PDF Version - 58 K)Contact: Marketed Health Products Directorate
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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.
Health Canada Endorsed Important Safety Information on Maalox Multi Action (bismuth subsalicylate)
May 12, 2010
Subject: Maalox Multi Action (bismuth subsalicylate) and confusion with other Maalox liquid products
Dear Health Care Professional,
Novartis Consumer Health Canada Inc., in consultation with Health Canada, would like to bring to your attention important safety information concerning the differences between our product Maalox Multi Action liquid and other Maalox liquid products.
Maalox Multi Action contains bismuth subsalicylate, which is chemically related to acetylsalicylic acid (ASA) and can lead to similar adverse effects, such as bleeding. Other Maalox liquid products are mineral based, contain different ingredients, and are indicated for different symptoms. However, due to the similarity in the name, label and package between Maalox Multi Action and other Maalox liquid products, they have the potential to be confused and result in medication incidents.
There have been Canadian reports of serious adverse events associated with the unintended use of Maalox Multi Action.
- Maalox liquid products contain different ingredients and are not interchangeable.
- Maalox Multi Action contains bismuth subsalicylate which is chemically related to acetylsalicylic acid (ASA).
- Maalox Multi Action has a similar name, package and label as other Maalox liquid products, which has caused unintended drug use resulting in serious adverse events.
- Maalox Multi Action is not recommended in patients with peptic ulcer disease, bleeding disorders, allergies to salicylates, pregnant women, in pediatric patients recovering from a viral disease such as chicken pox, and in patients taking anticoagulants, antiplatelet agents, NSAIDs or ASA-containing products.
- Because bismuth subsalicylate can blacken stools, its use has the potential to mask a gastrointestinal bleed or to be mistaken for a gastrointestinal bleed.
Healthcare professionals should refer to a Maalox liquid product by its full name or use the active ingredient name, when discussing with patients. 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. Patients should be encouraged to check Maalox liquid product labels carefully.
Novartis Consumer Health Canada Inc., in consultation with Health Canada, is developing measures to help eliminate potential consumer confusion. These will include a new name for Maalox Multi Action and a product label design changeto differentiate it from other Maalox liquid products. These changes will be phased onto the market during 2010.
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:
2233 Argentia Road, Suite 205, West Tower
Mississauga, ON, L5N 2X7
Telephone: 1-888-788-8181
Any suspected adverse reaction can also be reported to:
Canada Vigilance Program
Marketed Health Products Directorate
HEALTH CANADA
Address Locator: 0701E
Ottawa, Ontario, K1A 0K9
Telephone: 613-957-0337 or Fax: 613-957-0335
CanadaVigilance@hc-sc.gc.ca
To report an Adverse Reaction, consumers and health professionals may call toll free:
Telephone: 1-866-234-2345
Fax: 1-866-678-6789
Postage paid labels, the Canada Vigilance Reporting Forms and the Adverse Reaction Reporting Guidelines can be found on the MedEffectTM Canada Web site in the Adverse Reaction Reporting section. The Reporting Form is also in the Canadian Compendium of Pharmaceuticals and Specialties.
For other health product inquiries related to this communication, please contact Health Canada at:
Marketed Health Products Directorate
E-mail: mhpd_dpsc@hc-sc.gc.ca
Telephone: 613-954-6522
Fax: 613-952-7738
Should you have any questions regarding the use of Maalox Multi Action or any other Maalox product, please contact Novartis Consumer Health Canada Inc. at the address or telephone number listed above.
Sincerely,
original signed by
Don Beatty
Director, Regulatory and Scientific Affairs
Novartis Consumer Health Canada Inc.
