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FDA fails to issue warning on nonoxynol-9

FDA fails to issue warning on nonoxynol-9

A Government Accountability Office report scheduled for release this week says the Food and Drug Administration is putting people at risk of HIV infection and some other sexually transmitted diseases by failing to place a warning on the label of products containing the spermacide nonoxynol-9 to say that the compound can make such infections easier, The Washington Post reports. While the GAO report specifically says women are put at risk by nonoxynol-9 use because the compound can irritate vaginal and cervical tissue, studies have also found that condoms coated with the spermacide can put gay men who engage in anal sex at risk by similarly irritating anal tissues. Federal health agencies in the late 1980s began recommending nonoxynol-9 use as a way to possibly help prevent HIV infections, but reversed their positions a little more than a decade later when studies showed the compound actually increased infection risks. The Centers for Disease Control and Prevention in 2000 issued a warning about the compound, and most AIDS agencies routinely warn clients against nonoxynol-9 use. Several condom makers have stopped adding nonoxynol-9 to their products as a result of the studies showing it boosts HIV infection risks. The FDA in 2003 concluded that the compound was risky but has yet to issue any consumer warnings. The GAO report, prepared at the request of Sen. Tom Coburn (R-Okla.), says that by failing to issue a warning or to update labels of products containing nonoxynol-9, the FDA is putting the public at risk. "Since [the] FDA is still in the process of completing warning label changes for N-9 vaginal contraceptive products and condoms, the public may be left in doubt about the appropriate uses of these products until the FDA finalizes these warnings," the report says, according to the Post. "Further, the public may be at risk if the products are used inappropriately." Coburn called the FDA "derelict" by failing to warn the public about the increased HIV risks associated with nonoxynol-9, the Post reports. The FDA told the newspaper it couldn't report on the GAO report or proposed label changes.

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