Maalox Mix-up: FDA Warns of Dangers From Picking Wrong Variety
Novartis (NVS) sells several over-the-counter medications under the Maalox brand, and some varieties treat different symptoms using different active ingredients. In particular, the FDA warns of "potential serious side effects from mistakenly using Maalox Total Relief instead of other Maalox products as they contain different active ingredients."
Maalox Total Relief is intended to treat diarrhea, upset stomach associated with nausea, heartburn and gas due to overeating. Maalox's traditional liquid antacid products -- Maalox Advanced Regular Strength and Maalox Advanced Maximum Strength -- are for acid indigestion, heartburn, sour stomach, upset stomach and gas.
"Serious Medication Errors"
Maalox Total Relief's active ingredient is bismuth subsalicylate, which is chemically related to aspirin and may cause similar harmful side effects, such as gastrointestinal bleeding, the FDA said. That makes it inappropriate for individuals with a history of gastrointestinal ulcers or bleeding disorders, and it can have harmful interactions with blood thinners such as Plavix. The FDA lists other medications with which people should not take Maalox Total Relief, and specifies that children and teens shouldn't take it if they are recovering from viral infections.
There were at least five incidents of "serious medication errors" where people took Maalox Total Relief thinking it was Maalox antacid, the FDA warned.
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 renamed product is expected to begin selling in September 2010. Novartis will also conduct an educational campaign with consumers and health professionals and report adverse events associated with the use of Maalox brand products.
It will be interesting to see what name the Swiss drugmaker will choose for its rebranding of Maalox Total Relief, and how much its new marketing campaign for the product will cost. Regardless, for now, make sure that if you take Maalox, you're taking the right one for you.