Antigingivitis product warnings for periodontitis symptoms advised by FDA group.
This article was originally published in The Rose Sheet
Executive Summary
ANTIGINGIVITIS PRODUCT LABEL WARNING FOR SIGNS OF PERIODONTITIS RECOMMENDED by FDA's Dental Plaque Subcommittee during its meeting in Gaithersburg, Md. May 28. The product warning suggested by the advisory group states: "See your dentist immediately before use if you have pain or swelling of the gums, pus from the gumline, loose teeth or increased spacing between teeth. These signs or symptoms may be a sign of periodontitis, a more serious form of gum disease." The subcommittee also agreed a warning should be included on labeling for antigingivitis dentifrices that states: "If gingivitis, redness or bleeding persist for more than two weeks, see your dentist." Exact wording of the warnings may be changed to fit with FDA's proposed revisions to the OTC label format, the subcommittee noted.