Warning Issued for Birth-Control Patch By MARTHA MENDOZA, AP
National Writer
Fri Nov 11, 8:13 PM ET
The Food and Drug Administration warned users of the popular
Ortho Evra birth control patch that they are being exposed to more
hormones, and are therefore at higher risk of blood clots and other
serious side effects, than previously disclosed.
Until now, regulators and patch-maker Ortho McNeil, a Johnson and
Johnson subsidiary, had maintained the patch was expected to be
associated with similar risks as the pill. But a strongly worded
warning was added to the patch label Thursday that says women using
the patch will be exposed to about 60 percent more estrogen than
those using typical birth control pills.
"I wish I had known. It's quite likely I would never have used it,"
said Jennifer Cowperthwaite, 26, of Broad Brook, Conn., who still
suffers breathing problems after a blood clot reached her lungs two
years ago after using the patch.
Although most pills and the patch are loaded with the same amount of
estrogen, hormones from patches go directly into the bloodstream
while pills are swallowed and digested first. The result is that
women using the patch have much higher levels of estrogen in their
bodies.
Thursday's warning comes four months after The Associated Press
reported that patch users die and suffer blood clots at a rate three
times higher than women taking the pill.
Citing federal death and injury reports, the AP also found that
about a dozen women, most in their late teens and early 20s, died in
2004 from blood clots believed to be related to the birth-control
patch, and dozens more survived strokes and other clot-related
problems.
Ortho McNeil spokeswoman Bonnie Jacobs said the warning speaks for
itself and that the company has been cooperating with the FDA, which
distributed the new warning to health care providers.
More than 4 million women have used the patch since it went on sale
in 2002. Several lawsuits have been filed by families of women who
died or suffered blood clots while using the patch, and lawyers said
more are planned.
Documents released to attorneys as a result of that litigation show
Ortho McNeil has been analyzing the FDA's death and injury reports,
creating its own charts that document a higher rate of blood clots
and deaths in association with the patch than with the pill.
In addition, an internal Ortho McNeil memo shows that the company
refused, in 2003, to fund a study comparing its Ortho Evra patch to
its Ortho-Cyclen pill because of concerns there was "too high a
chance that study may not produce a positive result for Evra" and
there was a "risk that Ortho Evra may be the same or worse than
Ortho-Cyclen."
Last week, in response to AP questions about the Ortho McNeil memo,
company spokesman Michael Beckerich said in a written statement
that "decisions to fund studies are based upon scientific merit."
Beckerich said Ortho McNeil is conducting its own epidemiological
study "designed with input from the FDA and similar to those
previously conducted with the Pill."
New published studies show that women using the patch absorb about
50 percent more estrogen than with the pill, said Dr. Leslie Miller,
an associate professor of obstetrics and gynecology at the
University of Washington.
When women take the pill, the medication is absorbed into the
bloodstream through the digestive tract. In the process, about half
of the estrogen dose is lost.
Hormone levels in women on the pill are highest one or two hours
after taking it, Miller said. Twelve hours later, estrogen levels
are quite low, meaning the body is not exposed to high levels of
estrogen 24 hours a day.
But the patch causes higher estrogen levels since delivery of
medication continues all day. Those elevated levels may be high
enough to increase some women's risk of blood clots, Miller said.
"If the patch is delivering too much estrogen, then it may need to
be redesigned," Miller said. "Women should not just take off their
patch; they risk pregnancy. If they are worried and want to change
off the patch, they can wait to get something else."
Even before the warning, some advocacy groups and medical providers
were raising questions about the patch.
In September, Public Citizen's Health Research Group, a consumer
advocacy organization, added Ortho Evra to its ongoing list of
dangerous medicines, warning that there is "no medical reason for
women to use the more dangerous Ortho Evra rather than one of the
older, better understood, and equally effective oral
contraceptives."
And last month, Dr. Miguel Cano, an obstetrician and gynecologist in
Reedley, Calif., sent a note to several thousand women patients
recommending that they stop using the patch and that they come in
for appointments to get a new form of birth control.
Erika Klein's sister Kathleen Thoren died a year ago from blood
clots in her brain that the coroner said were brought on by Ortho
Evra. She said women deserve to be informed when making birth-
control decisions.
"Women have a right to know the true risks and make their decisions
based on that information," she said. "No one should have to go
through what my sister went through."