Alka-Seltzer alcohol warning "unjustified," Bayer says to FDA.
This article was originally published in The Tan Sheet
Executive Summary
ALKA-SELTZER ALCOHOL WARNING "UNJUSTIFIED," BAYER says in Jan. 28 comments on FDA's proposed beverage alcohol warnings for OTC analgesics. Alka-Seltzer, the effervescent gastrointestinal remedy product that contains aspirin, sodium bicarbonate and citric acid, differs from conventional aspirin in "several significant aspects," Bayer states. "As a result of [the] buffering system, and the form of aspirin that is ingested, the aspirin in the Alka-Seltzer solution (sodium salicylate) is present in the stomach almost completely in the ionized form," and, as such, "cannot enter the gastric mucosal cell," and therefore, cannot induce injury, the company maintains. "As Alka-Seltzer does not appear to induce GI damage, it is presumed that it does not have the same direct effect on the gastric mucosa that aspirin does."