by Playfuls Staff |
19th February 2006
Ortho Women's Health & Urology, the maker of the ORTHO EVRA (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 [more] 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 EVRA 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 EVRA.
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 EVRA 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 EVRA. 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 EVRA 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.
