FDA is keeping close watch on OTC drugs as well as prescription meds. The agency has ordered Novartis to rename and relabel one of its Maalox products, saying that the use of the Maalox name on meds with different active ingredients creates a health hazard. In the meantime, Novartis announced that it would publicize the differences between the two products.
The problem lies with Maalox Total Relief, a stomach and diarrhea remedy whose active ingredient is related to aspirin. The product shouldn't be combined with certain medicines or taken by certain population groups, such as people with bleeding disorders. Other Maalox products contain different active ingredients that don't carry the same risks.
In a statement, the FDA says it had observed five serious medication errors because of name confusion. So Novartis will change the name of Maalox Total Relief to remove the Maalox brand. And it will redesign the consumer label to minimize confusion with the products still labeled with the Maalox name. Novartis expects to start selling the new version in September.
- get the FDA release
- see the Wall Street Journal coverage