New guidance from the Food and Drug Administration proposes that latex condom labels inform users that condoms greatly reduce, but do not eliminate, the risk of pregnancy and the risk of contracting or spreading HIV or other sexually transmitted diseases.
The draft guidance from FDA, which is nonbinding, also recommends that the package insert for latex condoms say that condoms cannot protect against STDs such as human papilloma virus (HPV) and genital herpes when they are spread through contact with infected skin outside the area covered by the condom.
The draft guidance also includes statements that nonoxynol-9 could irritate the vagina and rectum and therefore may increase the risk of acquiring HIV/AIDS from an infected partner.
The proposed guidance is the result of a 5-year-old law that directs the FDA to ensure that condom labels are medically accurate, specifically with regard to their overall effectiveness in preventing STDs.
But the original congressional supporters of the provision—Sen. Tom Coburn (R-Okla.) and Rep. Mark Souder (R-Ind.)—are not completely satisfied with FDA's conclusions. “This is a step in the right direction,” Rep. Souder said in a statement. “Inasmuch as the new label recommendations finally acknowledge that condoms will not protect against some STDs.”
But he added that he is discouraged that FDA says that condom use may lower the risk of developing HPV-related diseases, such as genital warts and cancer.
The draft is available at www.fda.gov/cdrh/comp/guidance/1548.html