The packages say Maalox Advanced and Maalox Total Relief, and consumers might justifiably think that they are simply two versions of the same product. But they are not, and mix-ups have resulted in at least five reports of serious adverse reactions, the Food and Drug Administration said Wednesday. The drugs' manufacturer, Novartis Consumer Health Inc., has agreed to change the name and labeling of one of the products to minimize confusion, but that probably will not happen until September. Meanwhile, the FDA is cautioning consumers to be very careful when purchasing the over-the-counter products.
Maalox Advanced Regular Strength and Maalox Advanced Maximum Strength are antacids containing aluminum hydroxide and magnesium hydroxide, which neutralize acid in the stomach. Maalox Total Relief is an upset stomach reliever and anti-diarrhea medicine whose principal ingredient is bismuth subsalicylate, which is related to aspirin. Like aspirin, it can cause stomach bleeding. It should not be used by individuals with a history of gastrointestinal ulcer disease or a bleeding disorder, nor by children or teens recovering from a viral infection. It is also counter-indicated for patients taking oral anti-diabetic drugs, blood-thinning drugs and nonsteroidal anti-inflammatory drugs.
The FDA did not say what the adverse reactions were and Novartis has not said what the new name for Maalox Total Relief will be.
Image credit: FDA