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OTC DOXYLAMINE SACCHARIN-STYLE "HAZARDOUS," WARNING SUGGESTED BY FDA

Executive Summary

OTC DOXYLAMINE SACCHARIN-STYLE "HAZARDOUS," WARNING SUGGESTED BY FDA in a preliminary response to a June 14 recommendation of the Pulmonary-Allergy Drugs Advisory Committee. Acting rapidly on the advisory committee's review of recent doxylamine animal toxicology studies, FDA wrote to the Nonprescription Drug Manufacturers Association on July 19 to begin the process of proposing warning language. Using the saccharin warning as a model, FDA suggested a general doxylamine warning that the ingredient "may be hazardous" to humans based on animal test findings. The proposed caution would say: " WARNING: Use of this product may be hazardous to your health. This product contains doxylamine succinate which has been determined to produce tumors in laboratory animals." FDA's warning language is significant for at least two reasons: (1) for the speed with which the agency moved to translate a discussion of the need for a warning by the advisory committee into actual language; and (2) for the translation of the advisory committee's concern that consumers know about the animal data into a statement that the ingredient poses a potential hazard to humans. At the advisory committee meeting, committee member Leslie Hendeles, University of Florida, commented that it appears unlikely that the ingredient is a human carcinogen, but he suggested that the animal data from recent studies by the National Toxicology Program should not be "filed away somewhere without the American public being aware of it." The National Center for Toxicological Research published a report in mid-April linking doxylamine to hepatotoxicity in mice and hepatocellular adenomas and carcinomas in male rats. Procter & Gamble maintained at the FDA advisory committee meeting that the liver tumors were "well within the range of historical controls." FDA noted in its letter that the committee voted 5-1 to have OTC "labeling to advise consumers that doxylamine has produced tumors in laboratory animals." The agency portrays the "may be hazardous" format as a point of departure for developing a labeling proposal. FDA is setting a tight timetable for the relabeling action. The agency wants the first comments from industry by Sept. 5 before FDA begins developing a Federal Register notice. Division of OTC Drug Evaluation Director William Gilbertson told NDMA that FDA "would like to obtain the views of your association and its members on the above warning for doxylamine succinate-containing drug products prior to publishing it as a proposal in the Federal Register. Any suggestions you may have for alternative wording would also be considered." If FDA is successful in eliciting NDMA's comments and suggestions prior to developing the Federal Register notice, the agency could short-cut the long relabeling/warning process. FDA's decision to handle its response to the advisory committee discussion as a public process puts pressure on NDMA and the firms using doxylamine to participate or look obstructionist.

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