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COMMERCE DRUG's STYE (YELLOW MERCURIC OXIDE 1%) OTC

Executive Summary

COMMERCE DRUG's STYE (YELLOW MERCURIC OXIDE 1%) OTC can safely and effectively be used by consumers for eyelid infections, Jerome Bettman, MD, former First VP of the American Academy of Ophthalmology and Otolaryngology, maintained in an affidavit submitted to FDA by Commerce Drug counsel William Pendergast (D.C. law firm of Arent Fox) July 6. Pendergast is asking FDA to consider the affidavit before issuing the Final Monograph on Ophthalmic Drug Products. FDA classified mercuric oxide, and all other anti-infective agents, Category II in the Ophthalmic Tentative Final Monograph (TFM). The TFM, published in June 1983, maintains that ophthalmic anti-infectives are not appropriate for OTC use because consumers may not be able to distinguish a serious eye infection from a mild one and "there may be potential for serious harm to the eye if professional treatment is delayed." FDA's concern, Bettman said, "is not a sufficient reason to disapprove the OTC use of yellow mercuric oxide as an ophthalmic anti-infective . . . because the conditions for which [it] is indicated, such as blepharitis and stye, are infections of the eyelid, not the eye." Minor conditions of the eyelid, Bettman said, "are self-limiting and do not require treatment by a doctor, [whereas] serious infections of the eye itself result in significant pain, impairment of vision, and/or the condition called red eye . . . The danger of a consumer confusing an inflammation of the eyeball with a lid infection is almost nil." Bettman maintained that "even if the consumer were to use an OTC ophthalmic anti-infective to treat an eye infection, he would be adequately protected by a label warning that he should seek professional help if the condition does not improve after seven days. A delay of such a short period would not harm the consumer." The affidavit also cites three clinical studies on the safety of 1% mercuric oxide in the treatment of eyelid infections that were published after the TFM. The studies, Bettman said, "demonstrate the safety of 1% yellow mercuric oxide for OTC use when used for seven days." In addition, he said, "I have reviewed rabbit studies that showed no absorption of mercury into the bloodstream and no other adverse consequences following occular administration of a 1% yellow mercuric oxide product." Bettman suggested that FDA consider "that the availability of this product would make it less likely that a patient would use other preparations that may have significantly more harmful side effects." As an example he noted that "if such patients were to [self-medicate eyelid infections with] antibiotics, they could suffer an overgrowth of organisms that are insensitive to those drugs or develop a sensitivity to such medication."
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