Experts: Risk of Birth Control Patch Overstated
Much Less Blood-Clot Risk from Ortho Evra Patch Than From Pregnancy, Experts Say
WebMD News Archive
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.