GRANDPA BRANDS DENT'S TOOTHACHE GUM NEEDS SAFETY STUDY

GRANDPA BRANDS DENT'S TOOTHACHE GUM NEEDS SAFETY STUDY in a large group of patients "who would be likely to use the product," FDA told the firm in a June 17 letter. Responding to a proposed protocol submitted by Grandpa Brands to assess the occlusivity of the beeswax-containing toothache product, the agency suggested that "to establish the safety of a toothache relief formulation containing beeswax in a cotton matrix . . . enough patients should be enrolled in the study so that adverse events, if any exist, could be expected to appear." Dent's Toothache Gum contains eugenol and benzocaine as active ingredients. FDA suggested that Grandpa Brands conduct a larger study after determining that the protocol submitted by the firm "is not adequate to demonstrate that the beeswax used as an inactive ingredient in Dent's Toothache Gum is not occlusive." Besides asking for a larger study to demonstrate beeswax safety, FDA also wants "data supporting the safety and effectiveness of benzocaine and eugenol or a combination of the two ingredients." The agency placed benzocaine and eugenol in Category III (data insufficient to permit classification) in the 1991 tentative final monograph for OTC oral health care products. Mentholatum has submitted data on the effectiveness of eugenol alone in relieving toothaches, FDA pointed out, while Whitehall and Del Laboratories have offered data on the efficacy of benzocaine. FDA is "currently evaluating these data," the letter states. "No data have been submitted for a product containing both ingredients," the agency noted. FDA recommended to Grandpa Brands that the proposed study look at "how long patients are likely to use the product" and "whether appropriate professional dental treatment is delayed" while the product is used. Other questions that should be addressed, FDA said, are "whether pulpitis worsens due to use of the product"; "whether patients develop abscesses due to delay in seeking professional treatment or from the occlusive properties of the beeswax"; and "whether the product is likely to cause significant harm due to its use." "Inclusion and exclusion criteria should be clearly defined," FDA suggested. For example, the agency noted that enrollment could be limited to "adults between 20 to 50 years of age with severe and persistent toothache pain, open tooth cavities, and good overall physical health." Exclusion criteria, FDA said, could include "abscesses or suppurative osteitis, mucosal sores, Vincent's angina, allergy or sensitivity to the product(s), or certain pain levels (mild, barely noticeable, or none) at entry." In a January 1992 letter responding to the oral care TFM, Cincinnati-based Grandpa Brands informed FDA that it did not have the resources to conduct clinical studies on the efficacy of benzocaine and eugenol to relieve toothaches. Dent's Toothache Gum, along with Dent's Toothache Drops and Lotion-Jel, is manufactured by Grandpa Brands division C.S. Dents.