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Executive Summary

WHITEHALL's TODAY SPONGE LABELING PETITION SEEKS VAGINITIS WARNING in a renewed effort by two consumer watchdog groups. In a petition filed with FDA, the Associated Pharmacologists & Toxicologists and the Empire State Consumer Association request that FDA review the safety and effectiveness of Whitehall Labs' Today Sponge "in light of our continuing concerns regarding the possible carcinogenicity of the Sponge, and the reported adverse effects." Today has been on the market since July 1983 and is the leading OTC female contraceptive in the U.S., according to Whitehall. There have been 345 reports of vaginitis and 678 reports of unintended pregnancy during the OTC product's nine years on the market, according to the petition. The request for FDA review is based on data from the "FDA Spontaneous Reporting System," which has received a total of 2,962 reports about the sponge between 1983 and 1991, the two groups say. The labeling for Today currently contains a warning for Toxic Shock Syndrome and notes that "a small number of men and women may be sensitive to the spermicide in this product (nonoxynol-9) and should not use this product if irritation occurs and persists." APT states in its letter to FDA that the package insert does not make clear to consumers that cervical and vaginal irritation "are the most common complaints that have been associated with this product." The letter also notes that irritation is "predictable" because Today contains more nonoxynol 9 (1 gram/sponge) than any other OTC vaginal contraceptive "and the detergent is left in the vagina, with a polyurethane foreign body, longer than any other product." Whitehall characterized the number of reports of vaginitis as "relatively small" given the 150 mil. sponges sold over the nine- year period and "not unexpected for any nonoxynol-9 containing product." The company also noted that the efficacy rate for Today is 89%-91% "when used consistently and correctly." Whitehall said it "continues to have confidence in the safety and efficacy of Today Sponge." The two groups originally petitioned FDA in June 1983 to withdraw approval for Today until "adequate premarketing safety testing, consistent with the recommendations of the FDA Panel on Vaginal Contraceptives, has been completed and evaluated." A June 1984 supplement to the petition cited clinical reports suggesting that 12% of the women who use the sponge experience vaginal irritation. FDA did not respond to either submission, APT said.

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