Wednesday, April 13, 2005

Nonoxynol-9 Warning Labels--Not Yet

The Government Accountability Office (GAO) has released a new report about nonoxynol-9 (N-9) and the prevention of HIV: HHS: Efforts to Research and Inform the Public about Nonoxynol-9 and HIV (March 2005). The report's Concluding Observations are:

CDC’s and NIH’s efforts to research N-9’s potential use as a microbicide ended in 2000, when the preliminary results of a major clinical trial indicated that N-9 may actually increase the risk of contracting HIV. CDC has warned that N-9 may increase the risk of HIV transmission when used frequently, and some manufacturers of N-9 condoms have taken steps to either add their own warning labels or remove their N-9 condoms from the market, while other manufacturers have not taken such steps. FDA has proposed requiring new warning labels that indicate that N-9 vaginal contraceptive products do not protect against HIV or other STDs and that frequent use, such as more than once a day, may increase the risk of contracting HIV. FDA is also developing proposed warning labels for N-9 condoms. While FDA expects to issue the final rule for the new warning labels for vaginal contraceptive products by September 2005, it has not yet issued proposed warning labels for N-9 condoms, and it has not indicated a target date to issue the final warning labels for N-9 condoms. Since 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 FDA finalizes these warnings. Further, the public may be at risk if the products are used inappropriately.

There are any number of snarky comments that come to mind in response to this report, but I will forego them in order to point out that there needs to be a tad more haste in the slow progress of government processes when it comes to warning labels. My recollection is that repeated use of N-9 irritates mucous membranes and makes it easier for the virus to enter the bloodstream. Even if my recollection is off in terms of the exact problem, I'm still thinking we heard all of this several years ago. If folks are using out of date information for prevention messages ("Use latex condoms with N-9" used to be the recommendation), the delay in providing warning labels is inexcusable.

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