Much Less Blood-Clot Risk from Ortho Evra Patch Than From Pregnancy, Experts Say
By Daniel DeNoon
WebMD Medical News
Latest MedicineNet News
Reviewed By Brunilda
on Tuesday, July 19, 2005
July 19, 2005 -- Recent news stories overstate the blood clot risk from the Ortho Evra contraceptive patch, experts tell WebMD.
An Associated Press report says the contraceptive patch triples a woman's risk of dying from a dangerous blood clot. That calculation is based on the AP's own assessment of information contained in a 2001 report from an FDA medical reviewer and on all reported deaths since the patch became available in 2002.
Combination birth control pills result in one death per 200,000 women. If the AP calculations are correct, the risk from the patch is three deaths per 200,000 women.
The risk of dying from a pregnancy carried beyond 20 weeks is 20 to 25 deaths per 200,000 women.
WebMD Asks a Gynecologist
Is the patch less safe than the pill?
No, says Stephen Bashuk, MD, assistant professor at Emory University School of Medicine and director of obstetrics/gynecology residency training at Emory's Crawford Long Hospital.
"The risk from either the patch or the pill is very, very small," Bashuk tells WebMD. "Not being on the patch and getting pregnant is more dangerous than the patch itself."
Bashuk criticizes the AP study method. He says this kind of unscientific look-back study of very rare events in millions of women can lead to very misleading results.
For example, Bashuk notes that early data on newer combination estrogen and progestin birth control pills at first seemed to show that they were less safe than earlier birth control pills. As more data came in, he says, that fear turned out to be ungrounded.
"I will still prescribe the patch, absolutely," he says. "I think it is a good product that does what it is supposed to do."
WebMD Asks the Manufacturer
Ortho Evra manufacturer Ortho McNeil, a subsidiary of Johnson & Johnson and a WebMD sponsor, provided WebMD with a statement from Katherine LaGuardia, MD, director of medical affairs for Ortho Women's Health.
"The mortality rate associated with Ortho Evra use cited in the Associated Press story is misleading because it is based on spontaneous reports and inaccurate citation of clinical data," the statement says. "Spontaneous reports can come from various sources and there is a significant amount of uncertainty regarding the validity of the information."
LaGuardia also takes issue with two specific items in the AP report:
- "The AP report states a mortality rate of 3 in 200,000 from Ortho Evra clinical trials," she writes. "The data show and the product label reflect there were no fatal events associated with Ortho Evra during clinical trials."
- Ortho says that 2 million women used Ortho Evra in 2004. The AP story bases part of its calculations on 800,000 users.
WebMD Asks a Family Planning Expert
The AP notes that it wasn't the first organization to look at the safety of the Ortho Evra patch. It says that Vanessa Cullins, MD, MPH, MBA, vice president for medical affairs for the Planned Parenthood Federation of America, also looked at the data.
"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. That's 16 deaths from blood clots and heart attacks and strokes per 4.1 million woman-years. But women not taking contraceptives have pulmonary embolisms -- blood clots in the lung -- at a rate of 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.
SOURCES: Mendoza, M. Associated Press, "Birth-Control Patch May Pose Health Risk," July 17, 2005. Houn, F. Memorandum (FDA medical review of Ortho Evra), Nov. 20, 2001. FDA. Ortho McNeil. Katherine LaGuardia, MD, director, medical affairs, Ortho Women's Health. Stephen Bashuk, MD, assistant professor, Emory University School of Medicine; director, obstetrics/gynecology residency training, Crawford Long Hospital, Atlanta. Vanessa Cullins, MD, MPH, MBA, vice president for medical affairs, Planned Parenthood Federation of America.
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