Experts: Risk of Birth Control Patch Overstated
Much Less Blood-Clot Risk from Ortho Evra Patch Than From Pregnancy, Experts Say
WebMD News Archive
WebMD Asks a Family Planning Expert continued...
"We did an audit of the available data to see whether or not anything
unexpected is occurring with women using the Ortho Evra patch," Cullins
tells WebMD. "The answer to that, based on our audit, is no."
Cullins -- as the AP points out -- does serve as a consultant for Ortho
McNeil and for other pharmaceutical companies. But she says her focus is on
helping women choose between contraceptive options, not on product
What did the Planned Parenthood audit find? Cullins looks at the issue in
terms of woman-years -- that is, the number of women using the patch multiplied
by the number of years they used it.
The deaths of 16 women are linked to the contraceptive patch, although most
are not directly attributable to Ortho Evra. That's 16 deaths from blood clots
and heart attacks and strokes per 4.1 million woman-years. But women taking
oral combination contraceptives die of pulmonary embolisms -- blood clots in
the lung -- at a much higher rate: 41 cases per 4.1 million woman-years. And
that's not even counting deaths from heart attack and stroke.
"The risk of dying from pregnancy beyond 20 weeks is 10.7 per 100,000
live births. The expected death rate from Viagra is six per 100,000
prescriptions," Cullins says. "Sure, that is comparing apples and
oranges. But I am putting the risk from what is going on with Evra into context
so there will not be panic."
Neither birth control nor pregnancy, Cullins says, is without risk.
"There is a balancing of risk and benefits with any medical
decision," she says. "Where the balance lies will vary according to
that woman's risk factors, her desire to prevent pregnancy, and what is most
important to her as it relates to a choice of a contraceptive."
Some women, of course, should not take combination contraceptives such as
the Ortho Evra patch. They include:
- Women who smoke cigarettes, especially for women greater than 35 years
- Women with a previous or current blood clot either in the leg or a
- Some women with high blood pressure
- Women with markedly abnormal function of the liver
- Some women with diabetes
- Women who suffer prolonged immobilization, such as after major surgery
- Women who have just given birth. Hormonal contraceptives should be started
no earlier than four weeks after delivery in women who are not
- Women with a history of migraines with auras
Women with any of these conditions are twice as likely to suffer a blood