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Questions and Answers
Ortho Evra (norelgestromin/ethinyl estradiol)
1. What is FDA announcing today, September 20, 2006?
FDA is announcing an update to the
Ortho Evra label with the results of two separate epidemiology
studies sponsored by Johnson and Johnson that were designed to
evaluate the risk of experiencing serious side effects (especially
due to venous and arterial blood clots) when using Ortho Evra.
2. Is this information new?
Some of the information that is being
added to the Ortho Evra label was previously reported by Johnson and
Johnson on February 16, 2006 in a press release. Information in that
press release was based, in part, on an interim report from
one of the two epidemiological studies. The label is now being
updated with the available results from the two studies.
3. Why were these epidemiology
studies done?
These two epidemiology studies were
conducted to evaluate the risk of developing a serious blood clot in
women using Ortho Evra compared to women using a different, commonly
prescribed, oral contraceptive. Concern about this risk was
originally based on reports of serious blood clots to FDA and to the
sponsor that suggested that Ortho Evra may have a greater risk for
venous thromboembolism (VTE), at least in some women, compared to
oral contraceptives.
4. What information was found in
the two studies?
Both studies were conducted using
electronic health care claims data. However, the results of the two
studies are different.
The first study was conducted by the Boston Collaborative Drug
Surveillance Program. This study found that the risk of non-fatal
VTE events associated with the use of the Ortho Evra contraceptive
patch is similar to the risk associated with the use of oral
contraceptive pills (OCs) containing 35 micrograms of ethinyl
estradiol (an estrogen) and norgestimate (a progestin hormone).
The second study, which also included patient chart review, was
conducted by another group of investigators (i3 Ingenix). Results of
this second case-control study show an approximate 2-fold increase
in the risk of medically verified VTE events in users of Ortho Evra
compared to users of norgestimate-containing oral contraceptives
containing 35 micrograms of estrogen. Longer follow-up for VTE,
heart attack and stroke, has been requested by FDA.
5. What does this new information
mean to women who are using or considering using Ortho Evra?
Even though the results of the two
studies are conflicting, the results of the second epidemiology
study support FDA’s concerns regarding the potential for Ortho Evra
use to increase the risk of blood clots in some women. The label has
recommended and continues to recommend that women with concerns or
risk factors for thromboembolic disease talk with their healthcare
provider about using Ortho Evra versus other contraceptive options.
6. If a woman wants to change from
the Ortho Evra patch to a birth control pill, what should she do?
Talk to her health care professional.
The health care professional will help her make this change.
7. What other actions has the FDA
taken with regard to Ortho Evra?
In November 2005, the FDA added
information to the Ortho Evra label about the increased exposure to
estrogen seen in women who use Ortho Evra compared with oral
contraceptives containing norgestimate and 35 micrograms of ethinyl
estradiol based on the results of pharmacokinetic studies.
8. Where can I find more
information on this?
If you have further questions
regarding any medications, please contact the Center for Drug’s
Division of Drug Information at: 888-INFO-FDA (888-463-6332), or
email us at:
druginfo@fda.hhs.gov.
To view additional information on the use of Ortho Evra please visit
our website at:
http://www.fda.gov/cder/drug/infopage/orthoevra/default.htm
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Date created: September 20, 2006 |
