Why the Maalox Stomach-Bleeding Mixup Is the FDA's Fault
Novartis (NVS) will change the name of Maalox Total Relief after the FDA said it received five reports of serious medication errors involving consumers who thought that it was the same as traditional Maalox products. The new product name will not include the word "Maalox."
Maalox Total Relief contains bismuth subsalicylate, which is related to aspirin. It should not be used by people who have gastrointestinal ulcers or a bleeding disorder, the FDA said. Regular Maalox liquid products are antacids that contain aluminum hydroxide, magnesium hydroxide, and simethicone.
In some ways, this screwup isn't Novartis' fault. It's the FDA's fault. The government agency has a longstanding -- and completely insane -- policy of allowing two different drugs to be given the same brand name, or two identical drugs to be given different brand names. The Maalox mixup is an example of how that policy can hurt patients. It's the FDA's responsibility to prevent this kind of thing because companies won't be careful about it -- they want to extend the scope of their most-trusted brands into as many extension products as possible.
Another example: Johnson & Johnson (JNJ)'s Zyrtec and Merck (MRK)'s Claritin eye drops, neither of which contain Zyrtec or Claritin.
And both Pfizer (PFE)'s Viagra and Eli Lilly (LLY)'s Cialis are available as the hypertension drugs Revatio and Adcirca. Revatio must carry this obvious warning: "Avoid use with VIAGRA."
Clearly, brand name mixups are an accident waiting to happen under current FDA policy. The government should move to prevent them.