What's in a name? Plenty, the FDA says, when two medicines for different ailments have almost the same name.
The agency is warning consumers 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.
Meanwhile, the FDA has pressured Novartis Consumer Health to change the name of one of the products.
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 products are available without a prescription as over-the-counter liquid medications.
Under FDA pressure, Novartis 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, the agency said.
"Maalox Total Relief and Maalox are not interchangeable and shouldn't be used in place of each other," said 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."
Harmful 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.
Packaging and labeling of Maalox Total Relief and traditional Maalox Advanced Regular Strength and Maalox Advanced Maximum Strength are very similar and easily confused, the FDA says.
"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," said Holquist. "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 healthcare professionals to carefully check the labels of all Maalox products to ensure the appropriate product is being selected for the patient's symptoms.
