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Latex Condom Labels Would Bear N-9, STD Warnings Under FDA Proposal

This article was originally published in The Tan Sheet

Executive Summary

Labeling for condoms that employ nonoxynol-9 should be amended to state that spermicidal lubricants may increase HIV transmission, FDA says in a proposed rule published in the Federal Register Nov. 14

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FDA’s Proposed Condom Label Comprehension Study Submitted To OMB

FDA requests comment on a label comprehension study of current and proposed condom labeling as well as a future revised version, the agency states in a June 15 Federal Register notice

Condoms and HPV transmission

Women whose partners consistently use condoms have a significantly reduced risk of contracting Human Papillomavirus, a trial published in The New England Journal of Medicine June 22 finds. The study tracked 82 female university students who reported their first intercourse with a male partner either during the study period or within two weeks after enrollment. Samples of cervical and vulvovaginal samples were collected periodically, and the women kept electronic diaries recording information about their sexual behavior. Women whose partners used condoms for all instances of vaginal intercourse were 70% less likely to acquire a new infection than women whose partners used condoms less than five percent of the time, Rachel L. Winer, PhD, University of Washington, Seattle, et al., report. The research refutes other recent studies suggesting that male condom use does not reduce the risk of HPV infection in women. The authors note, however that "most data on condom use and HPV infection...are from cross-sectional studies and the prospective studies reported to date were not explicitly designed to evaluate condom use." A recent FDA proposal suggested warning statements about disease transmission on condom labeling 1("The Tan Sheet" Nov. 21, 2005, p. 13)...

Ansell on condom labels

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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