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Novartis’ woes with Maalox

March 2, 2010

The recent FDA warning issued to Novartis AG stemming from consumer misuse and subsequent serious illness from using Maalox Total Relief is a clear illustration of how important it is for consumers to clearly understand the active ingredients in OTC medications and how they can adversely affect someone especially if they have pre-existing conditions that would render them at serious risk by using the drug.

The FDA recently received several consumer complaints about “serious medication errors” related to mix ups in using Maalox brand name products.  It seems that due to confusion on Maalox Total Relief’s  drug labeling information, some consumers who were susceptible to dangerous side effects due to pre-existing conditions such as a history of gastrointestinal ulcer disease and bleeding disorders or people taking certain diabetes or anti-inflammatory drugs were not clear that an active ingredient called bismuth subsalicylate (chemically related to aspirin) would adversely affect them when using the product.  The consumer assumption was that because of the brand name “Maalox,” the OTC product would treat and relieve acid indigestion, heartburn sour stomach, upset stomach and pressure/bloating just as other Maalox products do.  The traditional Maalox liquid products, including Maalox Advanced Regular Strength and Maalox Advanced Maximum Strength, are antacid drug products that contain aluminum hydroxide, magnesium hydroxide and simethicone.

However, Maalox Total Relief’s active ingredient is different than its traditional products which was not clearly described on the drug label causing the confusion and serious illness in some consumer’s who used the product. Traditional Maalox liquid products such as Maalox Advanced Regular Strength and Maalox Advanced Maximum Strength are antacids. However, Novartis’ Maalox Total Relief, which is an upset-stomach reliever and antidiarrhea medication that has a different active ingredient.  The FDA reported there was a “potential for serious side effects from mistakenly using Maalox Total Relief instead of other Maalox products.”

The Wall Street Journal reported that, “The FDA said Novartis has agreed to change the name of Maalox Total Relief to one that doesn’t include the word “Maalox” and will change the drug’s packaging to avoid further confusion. However, sales of the renamed product won’t start until September, so the FDA urged consumers and health-care professionals to read Maalox product labels carefully.”

This case clearly demonstrates the need for consumers to be extra cautious before using OTC medications and take the time to read and understand drug label information before using these products.  At Medilyzer™, we are committed to providing consumers the ability to use our database as a means to protect themselves from unnecessary negative repercussions when using both prescription and OTC medications.  We dedicate our product mission to promoting awareness, safety and consumer empowerment to safeguard against adverse effects of using OTC and prescription medications.  We believe that by providing consumers this information, we can actively promote patient education and help to alleviate unnecessary health care expenditures resulting in the misuse of medications in the market.  Our solutions are available in four applications including a downloadable interface for your smart phone.

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