[02-17-2010] The U.S. Food and Drug Administration (FDA) has received five reports of serious medication errors involving consumers who used Maalox Total Relief, the upset stomach reliever and anti-diarrheal medication, by mistake, when they had intended to use one of the traditional Maalox liquid antacid products.
Due to the potential for serious adverse events from product confusion, the maker of Maalox brand products has agreed to:
- Change the name of Maalox Total Relief to one that will not include the name "Maalox" and revise the graphics and information displayed on the front of the product container to help distinguish the active ingredients and uses of this product from the traditional Maalox antacids.
- An educational program that includes outreach to healthcare professionals and consumers to inform them about the different products sold under the Maalox brand, including how to select the appropriate Maalox brand product.
- Active safety monitoring and reporting of adverse events associated with the use of Maalox brand products.
The company expects to begin selling the renamed product in September 2010. Until that time, healthcare professionals and consumers should be aware of the following:
- Maalox Total Relief and the traditional Maalox products are both liquid medications available without a prescription (OTC), but are NOT interchangeable. These products are intended to treat different medical conditions.
- Maalox Total Relief is not appropriate for individuals who want to use an antacid, especially if they have a history of gastrointestinal ulcer disease or a bleeding disorder.
- Maalox Total Relief contains the active ingredient bismuth subsalicylate and is used to treat diarrhea, upset stomach associated with nausea, heartburn, and gas due to overindulgence in food (overeating).Bismuth subsalicylate is chemically related to aspirin and may cause similar adverse effects such as bleeding. Bismuth subsalicylate has a warning statement stating that it should not be used in people who have or have a history of gastrointestinal ulcers or a bleeding disorder.
- Maalox Total Relief should not be used in children and teenagers if they are recovering from a viral infection. The product should also not be used in people who are taking oral anti-diabetic medications, blood thinning medications such as Coumadin (warfarin) or Plavix (clopidogrel), and non-steroidal anti-inflammatory drugs (NSAIDS) like ibuprofen and naproxen.
- The traditional Maalox liquid products including Maalox Advanced Regular Strength and Maalox Advanced Maximum Strength are well-recognized antacid drug products that contain aluminum hydroxide, magnesium hydroxide, and simethicone. Both are OTC products and are used for the relief of acid indigestion, heartburn, sour stomach, upset stomach, and pressure and bloating commonly referred to as gas.
- Maalox Total Relief should not be confused with traditional Maalox liquid antacid products.
FDA is concerned about the public health impact of medication mix-ups with products that have the same names or portions of the same name but contain different active ingredients. The agency encourages drug companies to consider the potential for name confusion when choosing OTC product names.
To help avoid potentially serious health risks associated with Maalox product mix-ups, the FDA recommends that consumers:
- Check with a healthcare professional or pharmacist if they are not sure what Maalox product is right for them.
- Carefully look at the labels of all Maalox products to make sure the right product is being purchased for the right condition.
- Read the active ingredients, uses and warnings in the "Drug Facts" box prior to purchasing any Maalox product.
- Report any side effects from the use of Maalox products to the FDA MedWatch program, using the information at the bottom of this page.
- When recommending an OTC product such as Maalox, refer to the product by its full product name (for example, Maalox Total Relief, Maalox Advanced Regular Strength, or Maalox Advanced Maximum Strength) or use the active ingredient name.
- Ensure that patients know the product name and understand the uses of the product prior to purchase.
- Report adverse events or medication errors involving Maalox products, such as using the wrong product because of confusing names, to the FDA MedWatch program using the information at the bottom of this page.
Maalox Total Relief and Maalox have similar packaging, but are not interchangeable.