Women were recently warned that their risk
of blood clots in the legs and lungs may be
higher if they use the birth-control patch
instead of the pill.
The
Food and Drug Administration said it
updated the label on the Ortho Evra birth-control
patch to reflect the results of one study
that found women using the patch faced twice
the risk of clots than did women on the pill.
However, a second study found no difference
in risk between the two forms of birth control.
"Even though the results of the two studies
are conflicting, the results of the second
epidemiology study support FDA's concerns
regarding the potential for Ortho Evra use
to increase the risk of blood clots in some
women," the FDA said in a notice published
on its Web site.
The risk of clots in women using either the
patch or pill is small. Even if it doubled
for those on the patch, perhaps just six women
out of 10,000 would develop clots in any given
year, said Dr. Daniel Shames, of the FDA's
Center for Drug Evaluation and Research.
Initial results of the two studies were made
public in February by the patch's manufacturer,
Ortho Women's Health & Urology. The Raritan,
N.J.-based company is owned by Johnson &
Johnson.
Last year an investigation by The Associated
Press, citing federal death and injury reports,
found higher rates of blood clots in women
using the patch.
The FDA recommended that women with concerns
about clots and use of the patch talk to their
doctors.
"We cannot conclude there is in fact a greater
risk," Shames said. "We are however concerned
enough about this information and we think
it is important enough information that it
should be given to consumers and to health-care
providers so they can make better choices."
In November, the FDA updated the label on
Ortho Evra to alert women that using the patch
exposes them to about 60 percent more estrogen
than using birth-control pills.
Johnson & Johnson previously has said
clots remains rare and that they have been
reported as a potential risk of all hormonal
contraceptives.
Ortho Women's Health & Urology said in
a statement that data will continue to be
collected for both studies. Shames said the
studies, which rely on insurance claims information
on upward of 500,000 women, would last another
18 to 24 months.
The company also said it would continue to
provide new information to the FDA.
The company reported in filings made last
month that Ortho Evra sales have declined
significantly following the previous label
revision and a spate of media coverage of
the clot issue. Since the patch went on sale
in 2002, more than 4 million women have used
it.
The company also disclosed that approximately
500 people have filed lawsuits or made claims
related to injuries they allegedly suffered
from the Ortho Evra patch.
The investigation by The Associated Press
found that patch users die and suffer blood
clots at a rate three times higher than women
taking the pill. About a dozen women died
in 2004 from blood clots believed linked to
use of the patch, the AP reported. Dozens
more suffered strokes and other clot-linked
problems.
Health officials warn that women who smoke
should not use the patch, since smoking increases
the risk of stroke and heart attack. Researchers
believe estrogen may promote coagulation of
the blood.
