The makers of a popular birth-control
patch warned millions of women Thursday that the patch
exposes them to significantly higher doses of hormones
and may put them at greater risk for blood clots and other
serious side effects than previously disclosed.
The warning from Johnson and Johnson
subsidiary Ortho McNeil, makers of Ortho Evra, says women
using the patch will be exposed to about 60% more estrogen
than those using typical birth-control pills because hormones
from patches get into the bloodstream and are removed
from the body differently than those from pills.
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 Thursday that the warning speaks for itself and that
the company has been cooperating with the Food and Drug
Administration, which distributed the new warning to health
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
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
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
Although the patch and most birth-control
pills contain the same amounts of estrogen, new published
studies show that women using the patch absorb about 50%
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
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."
Jennifer Cowperthwaite, 26, of Broad
Brook, Conn., still suffers breathing problems after a
blood clot reached her lungs two years ago while using
the patch. She said the warnings were long overdue.
"I wish I had known," she said. "It's
quite likely I would never have used it."
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
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