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OTC TOPICAL ANTIBIOTICS LABELING CHANGES TO HIGHLIGHT ALLERGIC REACTIONS

Executive Summary

OTC TOPICAL ANTIBIOTICS LABELING CHANGES TO HIGHLIGHT ALLERGIC REACTIONS are being implemented by Nonprescription Drug Manufacturers Association member companies. NDMA is proposing the changes in light of an increase in allergic hypersensitivity reactions seen in OTC topical antibiotics containing bacitracin zinc, neomycin and polymyxin B. NDMA is proposing to add to the warning sections of OTC topical antibiotics the language: "Stop use and consult a physician if condition persists or worsens or if a rash or other allergic reaction develops. Do not use this product if you are allergic to any of the listed ingredients." In a July 22 letter to NDMA, FDA suggested that the term "worsens" be changed to "gets worse." In a June 30 letter to FDA, NDMA informed the agency that its Topical Antibiotic Task Group had reviewed allergic hypersensitivity reports associated with the ingredients and had determined that "it might be of value to include reference to this possibility in the label warnings for OTC topical antibiotic products." The letter states that NDMA member companies "plan to implement these changes at the next printing of their labeling [and] in most cases the change will be implemented within one year. On Oct. 7, NDMA submitted data on allergic hypersensitivity reactions reported to have been associated with use of the topical antibiotics. The ingredients are found primarily in Burroughs Wellcome's Neosporin and Polysporin, Miles' Bactine, Sterling Health Campho-Phenique and Upjohn's Mycitracin. At the request of FDA, the association had reviewed the agency's adverse reporting database and submitted information showing 261 reports of allergic hypersensitivity associated with nonprescription drug products containing at least one of the three ingredients. By comparison, there were 631 allergic hypersensitivity reports attributed to prescription products containing the ingredients. In its Oct. 7 letter to the agency, NDMA noted that "a review of the enclosed sublistings of allergic reactions reportedly associated with OTC antibiotic products containing bacitracin, neomycin, and/or polymyxin B shows an increase in the total number of reports beginning in 1983." NDMA explained that "the increase in ADR reports is believed to be associated with an increase in the number of OTC products on the market." The association said, however, that "incidence figures cannot be generated from these data, since the denominator (total number of exposure) cannot be accurately determined and the numerator my be confounded by over- and/or under-reporting of adverse reactions."

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