Healthcare Industry News:  Transdermal 

Biopharmaceuticals Drug Delivery

 News Release - February 16, 2006

Results of Two Epidemiological Studies Provide Important New Clinical Information About the Safety of ORTHO EVRA(R)

RARITAN, N.J., Feb. 16 (HSMN NewsFeed) -- Ortho Women's Health & Urology, the maker of the ORTHO EVRAŽ (norelgestromin/ethinyl estradiol Transdermal system) birth control patch, has received the first results from two separate ongoing epidemiologic studies that were designed to evaluate the risk of experiencing serious side effects when using this form of hormonal birth control therapy. With the support of the study investigators, Ortho Women's Health & Urology is making this information available and sharing the data with the U.S. Food and Drug Administration (FDA) and other health authorities.

The objective of the first epidemiological study, which was conducted by the Boston Collaborative Drug Surveillance Program, was to evaluate the combined risk of heart attack and stroke in first-time users of ORTHO EVRAŽ compared with first-time users of a norgestimate-containing oral contraceptive (OC) with 35 micrograms of estrogen. The other objective of the study was to separately evaluate the risk of heart attack, stroke and venous thromboembolic events (VTE) in the same women. The first published paper from this study, which specifically evaluates the risk of nonfatal VTE, appears on the website of the journal Contraception. VTE includes deep vein thrombosis, otherwise known as DVT (blood clots in the large veins of the leg), and pulmonary embolism (blood clots in the lung). This study concludes that "the risk of nonfatal VTE for the contraceptive patch is similar to the risk for OCs containing 35 micrograms of ethinyl estradiol and norgestimate." The evaluation of the other study objectives, including the risk of heart attack and stroke is ongoing, but the currently available data do not show an increase in the risk of the combined endpoint of heart attack and stroke with the use of ORTHO EVRAŽ.

The interim report of the second study, which was conducted by i3 Drug Safety, an Ingenix company, will be published at a later date. The objective of this study was to evaluate the combined risk of heart attack and stroke in users of ORTHO EVRAŽ compared with users of a norgestimate-containing oral contraceptive with 35 micrograms of estrogen. The evaluation of the combined risk of heart attack and stroke is ongoing, but the currently available data do not show an increase in the combined risk of heart attack and stroke with the use of ORTHO EVRAŽ. The other objective of the study was to separately evaluate the risk of heart attack, stroke and VTE in the same women. The study shows an approximately two-fold increase in the risk of VTE in users of ORTHO EVRAŽ compared with users of the oral contraceptive. VTE is a relatively rare event but has been reported as a potential risk of all hormonal contraceptive therapy. Other analyses, including further evaluation of potential differences in risk factors between the two groups, are ongoing.

These studies were conducted using information from large medical insurance claims databases in the United States. The U.S. Food and Drug Administration (FDA) was consulted on the design of both studies, which utilize recognized methodology to assess the safety of oral contraceptives. Both studies were supported by research funding from Johnson & Johnson Pharmaceutical Research & Development.

ORTHO EVRAŽ is indicated for the prevention of pregnancy in women who elect to use a Transdermal patch as a method of contraception. The pharmacokinetic profile for the ORTHO EVRAŽ Transdermal patch is different from that of an oral contraceptive. Healthcare professionals should balance the higher estrogen exposure with ORTHO EVRAŽ against the chance of pregnancy if a contraceptive pill is not taken daily. It is not known whether there are differences in the risk of serious adverse events.

For more information about ORTHO EVRAŽ, please visit http://www.orthoevra.com, call 1-800-682-6532 or contact your healthcare provider.

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 EVRAŽ 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 EVRAŽ and a birth control pill containing 35 micrograms of estrogen.

You should discuss with your healthcare professional whether ORTHO EVRAŽ 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 & Urology

Ortho Women's Health & Urology, a division of Ortho-McNeil Pharmaceutical, Inc., is a leader in the fields of women's health and urology and is committed to providing patients with products that help them to live healthier lives. Ortho Women's Health & Urology, a trusted partner of healthcare professionals, is committed to meeting the needs of providers and patients with products such as ORTHO EVRAŽ (norelgestromin/ethinyl estradiol), ORTHO TRI-CYCLENŽ LO (norgestimate/ethinyl estradiol), DITROPAN XLŽ (oxybutynin chloride), and ELMIRONŽ (pentosan polysulfate sodium).


Source: Ortho Women's Health & Urology

Issuer of this News Release is solely responsible for its content.
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