FDA Warns about Serious Side Effects from Maalox Mix-Ups

The U.S. Food and Drug Administration warned consumers this week about the potential for serious side effects from mistakenly using Maalox Total Relief instead of other Maalox products. The two products are intended for the relief of different symptoms and contain different active ingredients.

Maalox Total Relief is an upset stomach reliever and anti-diarrheal medication, while traditional Maalox liquid products Maalox Advanced Regular Strength and Maalox Advanced Maximum Strength are antacids. Both Maalox Total Relief and Maalox are made by Novartis Consumer Health Inc. (NCH) and are available without a prescription as over-the-counter liquid medications. The maker of Maalox brand products has agreed to change the name of Maalox Total Relief to one that does not include the word "Maalox" and will change the drug's packaging to avoid further confusion and health-related consequences.

"Maalox Total Relief and Maalox are not interchangeable and shouldn't be used in place of each other," says Carol Holquist, R.Ph., director of FDA's Division of Medication Error Prevention and Analysis. "Consumer confusion and incorrect product use due to name confusion are serious public health issues. We appreciate Novartis' efforts to work collaboratively with FDA and their decision to remedy this situation to avoid any confusion over Maalox products in the future."

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.

Packaging and labeling of Maalox Total Relief and traditional Maalox Advanced Regular Strength and Maalox Advanced Maximum Strength are very similar and easily confused. Due to this confusion, NCH has agreed to:

  • 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.

Product Showcase

  • Full Line of Defense Against Combustible Dust Nilfisk

    Nilfisk provides a comprehensive range of industrial vacuums meticulously crafted to adhere to NFPA 652 housekeeping standards, essential for gathering combustible dust in Class I, Group D, and Class II, Groups E, F & G environments or non-classified settings. Our pneumatic vacuums are meticulously engineered to fulfill safety criteria for deployment in hazardous surroundings. Leveraging advanced filtration technology, Nilfisk ensures the secure capture of combustible materials scattered throughout your facility, ranging from fuels, solvents, and metal dust to flour, sugar, and pharmaceutical powders. Read More

  • The MGC Simple Plus

    The MGC Simple Plus is a simple-to-use, portable multi gas detector that runs continuously for three years without being recharged or routinely calibrated after its initial charge and calibration during manufacturing. The detector reliably tests a worksite’s atmosphere for hydrogen sulfide, carbon monoxide, oxygen and combustible gases (LEL). Its durability enables the detector to withstand the harshest treatment and environments, hence earning it an IP 68 rating. The MGC Simple Plus is also compatible with a variety of accessories, such as the GCT External Pump. Visit gascliptech.com for more information. Read More

  • SECUPRO MARTEGO

    FOR HIGHEST DEMANDS. A cutting tool in which function and design go hand in hand. Meet the SECUPRO MARTEGO, our prize-winning squeeze-grip safety knife with fully automatic retractable blade for safety. • Ergonomically friendly trigger mechanism to engage the blade • Durable body made of aluminum • Safer alternative to fixed blade utility knives for general cutting tasks • 9 mm Cutting depth • Easy, tool free blade change Dimensions: L 6.10" L x 0.71" W x 1.91" H Weight: 3.70 oz Cutting Depth: 9 mm Read More

Featured

Artificial Intelligence

Webinars