Maalox Total Relief is not interchangeable with other Maalox products, and the FDA is warning physicians and consumers about the potential for serious side effects when consumers pick the wrong product to treat their symptoms.
The agency said in a Feb. 17 news release(www.fda.gov) that the products are intended for the relief of different symptoms and contain different active ingredients.
Maalox Total Relief is an upset stomach reliever and antidiarrheal liquid medication, while traditional Maalox liquid products -- Maalox Advanced Regular Strength and Maalox Advanced Maximum Strength -- are antacids. All three products, which are manufactured by Novartis Consumer Health Inc., are OTC medications.
The active ingredient in Maalox Total Relief is bismuth subsalicylate, which is chemically related to aspirin and may cause harmful side effects similar to those seen with aspirin use, such as gastrointestinal bleeding. The FDA said patients with a history of gastrointestinal ulcer disease or a bleeding disorder should not use it.
Maalox Total Relief also is inappropriate for children and teens recovering from viral infections and individuals who are taking certain medications, including oral antidiabetic drugs, anticoagulants, nonsteroidal anti-inflammatory drugs and other anti-inflammatory drugs.
The traditional Maalox liquid products, including Maalox Advanced Regular Strength and Maalox Advanced Maximum Strength, are antacid products that contain aluminum hydroxide, magnesium hydroxide and simethicone. Those products are used for the relief of acid indigestion, heartburn, sour or upset stomach, and gas.
The FDA said it has received five reports of serious medication errors involving consumers who mistakenly used Maalox Total Relief when they had intended to use one of the traditional Maalox antacid products.
The agency said in a safety announcement(www.fda.gov) that when recommending an OTC medicine, physicians should refer to the product by its full name or use the name of the active ingredient. Physicians also should ensure that patients know the uses of the product prior to purchase.
Physicians are encouraged to report adverse events or medication errors involving Maalox products to the FDA's MedWatch program(www.accessdata.fda.gov).
The FDA said Novartis has agreed to change the name of Maalox Total Relief to one that does not include the word "Maalox." The manufacturer also plans to change the product's packaging.
The rebranded product is expected to be available in September. Until then, the FDA is advising consumers to carefully check the labels of all Maalox products to ensure they are selecting the appropriate product to relieve their symptoms.
Novartis also has agreed to conduct an educational campaign regarding the products with outreach to both physicians and consumers, the FDA said.