Proposed condom labels warn against spermicide

WASHINGTON (Reuters) - New draft guidelines for male latex condoms published on Thursday call for packaging to include information they reduce, but do not eliminate, the risk of pregnancy and sexually transmitted diseases.



The U.S. Food and Drug Administration guidelines also specifically say condoms that contain the spermicide nonoxynol-9 must specify that they can cause irritation and increase the risk of HIV, the virus that causes AIDS.

They 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, required by law, also address incorrect or inconsistent use, saying condoms should be thrown away -- not flipped over -- if not unrolled correctly.

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

Congress 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.

Some health activists have also expressed concern that too many warnings may discourage use altogether.

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

"The new guidance for condom labels issued today by the FDA recognizes that current condom claims do not meet this medical standard," said Sen. Tom Coburn, an Oklahoma Republican and physician who has pressed for the changes.

Coburn said he welcomed the new nonoxynol-9 warning but rejected the claims about HPV, a virus that can cause cervical cancer. "The agency continues to promote inconclusive assurances that put women unknowingly at risk for cervical cancer, or worse," he said.

Other lawmakers, including California Democratic Rep. Henry Waxman (news, bio, voting record), have said that government studies support condom use to prevent HPV.

FDA officials said 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.

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.

"It's behind the times. Condoms in today's world are much more used for disease prevention than pregnancy prevention," AIDS Healthcare Foundation President Michael Weinstein said.

The public can comment on the guidelines for 90 days before the FDA makes its final recommendation.