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Ansell on condom labels

This article was originally published in The Tan Sheet

Executive Summary

FDA's proposed warnings for condoms employing the spermicide nonoxynol-9 are "alarmist and unwarranted" because "there are no studies linking N-9 condoms to vaginal irritation and increased transmission of HIV," Ansell Healthcare Products states in Feb. 10 comments to the agency. N-9 studies that have shown an increased transmission of HIV "involved different vehicles (gels and suppositories) as well as dramatically higher doses (50 mg-150 mg vs. < 32 mg)" than is typical of N-9 condoms, the LifeStyles manufacturer adds. The agency proposed label warnings in November which would state that N-9 can increase the risk of getting HIV/AIDS from an infected partner if used regularly (1"The Tan Sheet" Nov. 21, 2005, p. 13). Ansell also objects to including in labeling a table comparing various contraceptive methods because it contains "Typical Use" rates, which are "not based on scientifically valid data."...
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