FDA orders Novartis to rename high-dose Maalox to avoid confusion with milder drug

FDA orders name change for Maalox Total Relief

WASHINGTON — The maker of Maalox has agreed to change the name of its most potent medication, after federal health regulators said consumers have been mistaking it for a milder stomach reliever.

The Food and Drug Administration warned consumers Wednesday that Maalox Total Relief contains potent drug ingredients that can cause internal bleeding. The anti-diarrhea medication is often confused with traditional Maalox, which uses a gentler formula to neutralize stomach acid.

Both products are available over-the-counter without a prescription.

The FDA said Swiss manufacturer Novartis will rename Maalox Total Relief and change its packaging to avoid confusion. The rebranded product should be available by September.

“We want companies to consider the potential for name confusion when choosing names for their drugs,” said Carol Holquist, FDA’s director for medication error prevention.

The medication at issue contains bismuth subsalicylate, a chemical similar to aspirin which can exacerbate bleeding in patients with stomach ulcers and blood clotting problems.

In addition to those patients, the FDA said high-strength Maalox should not be taken by children and teenagers recovering from a virus or patients taking certain medications. Maalox Total Relief can negatively interact with blood thinners like warfarin and Plavix, as well as anti-inflammatory drugs like aspirin.

Novartis will also conduct an educational campaign for doctors and consumers, explaining how to choose the appropriate Maalox product.

Novartis is one of the world’s top five drugmakers by sales. The Basel-based company makes the blockbuster blood pressure drug Diovan, cancer treatments Gleevec and Zometa, and a host of consumer products, including Gas-X, Excedrin, Benefiber and Theraflu.