The U.S. Food and Drug Administration (FDA) issued a critical warning to consumers about two Maalox products. Taking the wrong Maalox can result in serious side effects. The warning concerns the product called Maalox Total Relief which can be confused with other Maalox products.
According to Carol Holquist, R.Ph., Director of FDA’s Division of Medication Error Prevention and Analysis "Maalox Total Relief and Maalox are not interchangeable and shouldn’t be used in place of each other,”
Maalox products have traditionally been used as an antacid to treat heartburn. An over-the- counter drug which does not require a prescription, it includes liquid products and is sold under the names:
Maalox Advanced Regular Strength and
Maalox Advanced Maximum Strength
Maalox Total Relief’ is intended to treat upset stomach and diarrhea. Although the packaging is very similar to other Maalox products, mixing the products up could cause serious and even life threatening side effects. Maalox Total Relief's active ingredient (bismuth subsalicylate) is chemically related to aspirin and may cause similar harmful side effects such as bleeding. As such, Maalox Total Relief is not appropriate for individuals with a history of gastrointestinal ulcer disease or a bleeding disorder. Maalox Total Relief also should not be taken by children and teens if they are recovering from a viral infection, nor by individuals who are taking certain medications including: oral antidiabetic drugs (OADs), anticoagulation (thinning the blood) drugs such as warfarin (Coumadin) and clopidogrel (Plavix), non-steroidal anti-inflammatory drugs (NSAIDS), and other anti-inflammatory drugs.
The following is a partial list of persons who should not take Maalox Total Relief:
- a person with a history of gastrointestinal ulcer disease,
- a person with a bleeding disorder,
- children and teens if they are recovering from a viral infection.
In addition, Maalox Total Relief’ should not be taken by people who are on certain medications including
- oral antidiabetic drugs (OADs),
- anticoagulation (thinning the blood) drugs such as warfarin (Coumadin) and clopidogrel (Plavix),
- non-steroidal anti-inflammatory drugs (NSAIDS), and
- other anti-inflammatory drugs.
The FDA reported that they knew of five cases of serious side effects in people who mistook Maalox Total Relief for one of the Maalox antacid products.
- Change the name of Maalox Total Relief to one that does not include the root name Maalox as well as change the product label design;
- Conduct an educational campaign with outreach to health care professionals and consumers regarding different Maalox products and ways to select the appropriate Maalox brand product; and,
-- Actively monitor and report adverse events associated with the use of Maalox brand products.
"The FDA is concerned about the public health impact of medication mix-ups for products that have the same names or portions of the same name, but contain different active ingredients," Holquist said. "We want companies to consider the potential for name confusion when choosing names for their drugs."
The renamed product is expected to begin selling in September 2010. Until that time, FDA is advising consumers and health care professionals to carefully check the labels of all Maalox products to ensure the appropriate product is being selected for the patient’s symptoms. Any Maalox side effects or other product problems should be reported to FDA's MedWatch Adverse Event Reporting program at www.fda.gov/MedWatch or by calling 1-800-332-1088.
Source: FDA press release
By Mortin - Copyright 2010
Last modification 20/02/2010