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Experts: Risk of Birth Control Patch Overstated

Much Less Blood-Clot Risk from Ortho Evra Patch Than From Pregnancy, Experts Say

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 promotion.

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 old
  • Women with a previous or current blood clot either in the leg or a lung
  • 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 breastfeeding.
  • Women with a history of migraines with auras

Women with any of these conditions are twice as likely to suffer a blood clot.


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