Maalox Monitoring

FDA warns of potential confusion over Maalox products.
The AP (2/18, Perrone) reports that the FDA "warned consumers Wednesday that Maalox Total Relief contains potent drug ingredients that can cause internal bleeding." The product "is often confused with traditional Maalox, which uses a gentler formula to neutralize stomach acid."
The "upset stomach reliever and anti-diarrhea medicine" contains "bismuth subsalicylate," which "can cause stomach bleeding," the Los Angles Times (2/17, Maugh) "Booster Shots" blog reported. The product "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."
The Wall Street Journal (2/18, Dooren) reports that Maalox manufacturer Novartis AG will halt sales of the products under the same brand name after the FDA announced that it received reports of medication errors linked to confusion over the two. The agency said the name Maalox Total Relief will no longer include the word Maalox and Novartis will alter the drug's packaging.
WebMD (2/17, DeNoon) reported that "the new label won't appear until September." Novartis will launch "an outreach program" until then to "warn consumers and medical professionals about the difference between the two product types." Novartis will also conduct active safety monitoring and reporting of adverse events associated with Maalox brand products." Dow Jones Newswire (2/18) and MedPage Today (2/17, Petrochko) also covered the story.