|
Government
Report Faults FDA Failure to Include in Label Risk of HIV Transmission
from Nonoxynol-9
FDA’s
failure to update the labels of products containing the spermicide
nonoxynol-9 to warn of the increased risk of contracting
HIV among women who use the products puts consumers at risk, according
to a Government Accountability Office report scheduled to be released
on Tuesday, the Washington Post reports (Connolly, Washington Post, 4/12).
Nonoxynol-9 works as a vaginal
contraceptive
by damaging the cell membranes of sperm, and some laboratory evidence
has shown that the spermicide damages the cell walls of some organisms
that cause sexually transmitted diseases and is active against some
bacteria and viruses. However, according to data presented in January
2003, nonoxynol-9's membrane-damaging effect also can harm the cell
lining of the vagina and cervix, possibly increasing the risk of contracting
sexually
transmitted diseases,
including HIV, among women who use it (Kaiser Daily HIV/AIDS Report, 3/24/04).
Although
the U.S. surgeon general, FDA, CDC and NIH in 1988 said that condoms with nonoxynol-9 might provide
additional protection against HIV, CDC in 2000 revised its guidelines
and warned that the spermicide "may actually increase the risk
of contracting HIV when used frequently." FDA in 2003 concluded
that nonoxynol-9 might increase a person's risk of contracting HIV,
but so far the agency has not issued new consumer warning labels,
according to the Post.
Report
Details
The
new report -- which was prepared at the request of Sen. Tom Coburn
(R-Okla.) -- criticizes FDA for not publicizing scientific evidence
and information showing that nonoxynol-9 does not protect against
HIV. "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," the report says,
adding, "Further, the public may be at risk if the products are
used inappropriately." FDA said it could not comment on the GAO
report or proposed label changes, the Post reports.
Coburn
Comments
"The
FDA is derelict," Coburn said, adding, "They've known nonoxynol-9
increases your risk of HIV, and every day they don't put that out
they are harming people." He also said that FDA and CDC have
an "institutional bias" toward "safe sex rather than
responsible sexual activity," adding, "My definition of
responsible sexual activity is monogamy with limited partners and
delayed onset of sexual activity."
In the past, Coburn has encouraged health agencies to "cast condoms
in a dramatically different light," saying that public health
officials should warn consumers about the misuse of condoms and their
failure rates for preventing pregnancy and STDs, according to the
Post. For example, Coburn has said that no evidence exists
to show that condoms protect against certain STDs, including human papillomavirus, which causes most cases
of cervical cancer (Washington Post, 4/12). NIH in 2001
released a report saying that there is insufficient evidence that
male latex condoms prevent transmission of STDs other than HIV and
gonorrhea (Kaiser Daily HIV/AIDS Report, 6/20/01).
Some
Companies No Longer Use Nonoxynol-9
The World Health Organization and UNAIDS also have raised concerns about the use of nonoxynol-9
in condoms. As a result, several companies -- including SSL International,
the maker of Durex
condoms; Johnson & Johnson, which makes
K-Y brand personal lubricant; and Mayer
Labs, which makes the Kimono brand of condom -- have stopped manufacturing
condoms with nonoxynol-9 (Kaiser Daily HIV/AIDS Report, 1/21/04).
04/13/05
Source
Kaiser Daily HIV/AIDS Report.
FDA Failure To Update Nonoxynol-9 Labels To Mention Increased
Risk of Contracting HIV Puts People At Risk, GAO Report Says. April
12, 2005.
|
|
