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