Warnings to be put on condoms

Nov 14 2005

The U.S. Food and Drug Administration (FDA) is calling for warnings to be placed on condoms.

The FDA draft guidelines for male latex condoms want the packaging to include information they reduce, but do not eliminate, the risk of pregnancy and sexually transmitted diseases.

The guidelines specifically state that condoms that contain the spermicide nonoxynol-9 can cause irritation and increase the risk of HIV, the virus that causes AIDS.

They do also specify that consistent condom use may help protect against some other sexually transmitted diseases, such as human papilloma virus, or HPV, that are transmitted through skin contact.

The draft labels, which are required by law, also address the issue of incorrect or inconsistent use, saying condoms should be thrown away, if not unrolled correctly.

Condom packaging is already required to carry certain warnings about the risk of pregnancy and disease.

Congress had called for the new FDA proposal to ensure condom labels were "medically accurate," but there has been debate between lawmakers and FDA scientists about what should be included, and some health activists are concerned that too many warnings could discourage use.

The agency's recommendations give specific language manufacturers can use to meet the FDA's current labeling rules, and though not mandatory, most companies follow them.

Senator Tom Coburn, an Oklahoma Republican and physician who has pressed for the changes, says that current condom claims do not meet medical standards.

While he welcomes the new nonoxynol-9 warning, he rejects the claims about HPV, a virus that can cause cervical cancer.

Coburn believes that the FDA is promoting inconclusive assurances that put women unknowingly at risk for cervical cancer, or worse.

Many others say however that government studies support condom use to prevent HPV.

According to FDA officials they suggested the labeling after conducting an "extensive review" of relevant medical literature in consultation with the National Institutes of Health and the Centers for Disease Control and Prevention.

Previous studies have shown nonoxynol-9 can irritate the vagina and rectum, allowing HIV to more easily pass through the tissue.

One AIDS activist group, which has lobbied manufacturers to stop including nonoxynol-9 in condoms, welcomed the warning but said it should have come sooner, as condoms in today's world are much more used for disease prevention than pregnancy prevention.