RARITAN, N.J., Jan. 18 /PRNewswire-USNewswire/ -- Ortho Women's Health
& Urology(TM), Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., has
updated the prescribing information for ORTHO EVRA(R)
(norelgestromin/ethinyl estradiol transdermal system) to include further
epidemiologic data.
The revised labeling includes two new additional estimates of relative
risk (odds ratios) for venous thromboembolic events (VTE) of 1.1
(indicating no increase in risk) and 2.0 (indicating an approximate
doubling of risk) in women using ORTHO EVRA compared to women using birth
control pills. The previous labeling reported two estimates of relative
risk for VTE of 0.9 (indicating no increase in risk) and 2.4 (indicating an
approximate doubling of risk). This information is presented in a table in
the WARNINGS section and is available at http://www.fda.gov and http://www.orthoevra.com.
The results from all of these epidemiologic studies can be found on
http://www.clinicaltrials.gov or by calling Ortho-McNeil Janssen Scientific
Affairs, LLC Customer Communications Center at 1-800-526-7736.
The detailed patient information for ORTHO EVRA also has been revised
to include this information in the OTHER CONSIDERATIONS BEFORE USING ORTHO
EVRA section.
ORTHO EVRA is a hormonal birth control option and is safe and effective
when used according to the product label. The Company consulted with the
U.S. Food and Drug Administration on this label change. ORTHO EVRA, like
all hormonal birth control, has risks and benefits. It is important that
women speak to their health care professional to determine the option that
is right for them.
ORTHO EVRA is indicated for the prevention of pregnancy in women who
elect to use a transdermal patch as a method of contraception.
For more information about ORTHO EVRA, please visit http://www.orthoevra.com,
call Ortho-McNeil Janssen Scientific Affairs, LLC Customer Communications
Center at 1-800-526-7736 or contact your health care professional.
Important Safety Information
Serious as well as minor side effects have been reported with the use
of hormonal contraceptives. Serious risks include blood clots, stroke and
heart attacks. Cigarette smoking increases the risk of serious
cardiovascular side effects, especially in women over 35. Women who use the
contraceptive patch are strongly advised not to smoke.
The pharmacokinetic (PK) profile for the ORTHO EVRA patch is different
from the PK profile for oral contraceptives in that it has higher steady
state concentrations (60% higher) and lower peak concentrations (25% lower)
of ethinyl estradiol (EE) compared with an oral contraceptive containing 35
mcg EE. It is not known whether there are changes in the risk of serious
adverse events based on the differences in PK profiles of EE in women using
ORTHO EVRA compared with women using oral contraceptives containing 35 mcg
EE. Increased estrogen exposure may increase the risk of adverse events,
including venous thromboembolism. (See CLINICAL PHARMACOLOGY, Transdermal
versus Oral Contraceptives, BOLDED WARNING in the Package Insert).
The results of epidemiologic studies evaluating the risk of venous
thromboembolism (VTE) among women using ORTHO EVRA compared to those using
oral contraceptives containing 30-35 mcg EE and either levonorgestrel or
norgestimate reported odds ratios ranging from 0.9 (no increase in risk) to
2.4 (approximate doubling of risk).
The Patch does not protect against HIV or sexually transmitted
diseases.
Please see full U.S. Prescribing Information at http://www.orthoevra.com.
About Ortho Women's Health & Urology(TM)
Ortho Women's Health & Urology(TM), Division of Ortho-McNeil-Janssen
Pharmaceuticals, Inc., is a leader in the fields of women's health and
urology, celebrating more than 75 years of partnering with women. Ortho
Women's Health & Urology is committed to helping people live healthier
lives and to meeting the needs of providers and patients with products such
as ORTHO TRI-CYCLEN(R) LO (norgestimate/ethinyl estradiol), ORTHO EVRA(R)
(norelgestromin/ethinyl estradiol transdermal system), and
ELMIRON(R)(pentosan polysulfate sodium). For more information on these
products, birth control, bladder health or general women's health issues,
please visit http://www.orthowomenshealth.com.
SOURCE Ortho Women?s Health & Urology
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Related links:
http://www.clinicaltrials.gov
http://www.fda.gov http://www.orthoevra.com
http://www.orthowomenshealth.com
CONTACT:
Gloria Vanderham of Ortho Women's Health &
Urology, +1-908-927-3756, gvanderh@ompus.jnj.com
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