US FDA Warns About Johnson & Johnson Patch Hormone Levels
RARITAN, N.J., Nov. 10 /PRNewswire/ -- Ortho Women's Health, a unit of Ortho-McNeil Pharmaceutical, Inc., has updated the WARNINGS section of the prescribing information for ORTHO EVRA® (norelgestromin/ethinyl estradiol transdermal system) as follows:
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 and lower peak concentrations. AUC and average concentration at steady state for ethinyl estradiol (EE) are approximately 60% higher in women using ORTHO EVRA® compared with women using an oral contraceptive containing EE 35 micrograms. In contrast, peak concentrations for EE are approximately 25% lower in women using ORTHO EVRA®. Inter-subject variability results in increased exposure to EE in some women using either ORTHO EVRA® or oral contraceptives. However, inter-subject variability in women using ORTHO EVRA® is higher. In general, increased estrogen exposure may increase the risk of adverse events. However, it is not known if there are changes in the risk of serious adverse events based on the differences in pharmacokinetic profiles of EE in women using ORTHO EVRA® compared with women using oral contraceptives containing 35 micrograms of EE.
Additional updates to the prescribing information for ORTHO EVRA® include new language to the INDICATIONS AND USAGE, DESCRIPTION, DOSAGE AND ADMINISTRATION and CLINICAL PHARMACOLOGY sections.
The DETAILED PATIENT LABELING for ORTHO EVRA® has also been revised to include new information in the DESCRIPTION, OTHER CONSIDERATIONS BEFORE USING ORTHO EVRA® and HOW TO USE ORTHO EVRA® sections.
This labeling change is effective immediately and, in addition, will also be communicated to the medical community via a Dear Healthcare Professional Letter. We encourage patients who use ORTHO EVRA® and have questions to contact their physician.
Since the introduction of ORTHO EVRA® in 2002, Ortho Women's Health has maintained an ongoing clinical development program for ORTHO EVRA® which is designed to further characterize the potential benefits and safety of this product. The company is conducting two epidemiological studies that were designed with input from the U.S. Food and Drug Administration (FDA) and are similar to those previously conducted with oral contraceptives. Results from an initial analysis of the first epidemiological study have been submitted to the FDA and also submitted for publication.
ORTHO EVRA® has been used by more than five million women and remains a safe and effective product, when used according to the product's label. However, hormonal contraception is not suitable for all women. It is important that women speak with their healthcare professionals about what option is right for them.
For more information about ORTHO EVRA®, please visit http://www.orthoevra.com or call 1-800-682-6532.
Important Safety Information
Most side effects of the Patch are not serious and those that are occur infrequently. Serious risks, which can be life threatening, include blood clots, stroke and heart attacks and are increased if you smoke cigarettes. Cigarette smoking increases the risk of serious cardiovascular side effects, especially if you are over 35. Women who use the Patch are strongly advised not to smoke. Some women should not use the Patch, including women who have blood clots, certain cancers, a history of heart attack or stroke, as well as those who are or may be pregnant.
Hormones from patches applied to the skin get into the blood stream and are removed from the body differently than hormones from birth control pills taken by mouth. You will be exposed to about 60% more estrogen if you use ORTHO EVRA® than if you use a typical birth control pill containing 35 micrograms of estrogen. In general, increased estrogen exposure may increase the risk of side effects. However, it is not known if there are differences in the risk of serious side effects based on the differences between ORTHO EVRA® and a birth control pill containing 35 micrograms of estrogen.
You should discuss with your healthcare professional whether ORTHO EVRA® is a good method of contraception for you. 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
For more than 74 years, Ortho Women's Health, a unit of Ortho McNeil Pharmaceutical, Inc. and marketers of ORTHO EVRA®, ORTHO TRI-CYCLEN® LO and ORTHO TRI-CYCLEN®, has listened to women's needs and responded with products and information to help them live healthier lives. Ortho Women's Health, a trusted partner of healthcare professionals, is committed to bringing women the most advanced options in contraception. By delivering superior and innovative products, services, and education, Ortho Women's Health helps empower women to make the right choice for themselves and their bodies. For more information, visit http://www.orthoevra.com, http://www.thepill.com, or http://www.orthowomenshealth.com.
Source: Ortho Women's Health