Recent Advances in Oral and Transdermal Contraception

Peggy Piascik, PhD

Disclosures

US Pharmacist. 2008;33(9):19-23. 

In This Article

Transdermal Contraceptive Patch

The Ortho Evra contraceptive patch, a matrix system containing 6 mg norelgestromin and 0.75 mg ethinyl estradiol, was approved in 2001. Proposed advantages include improved adherence to the regimen and better efficacy if errors of up to two days are made in dosing. This dosing method avoids first-pass metabolism of hormones, gastrointestinal enzymatic degradation, and peaks and troughs in drug levels. It is easy to confirm the presence of the patch, which reassures the user of continued protection. Disadvantages are application-site reactions and decreased efficacy in patients weighing more than 198 lb.[23]

The FDA revised the labeling for Ortho Evra in September 2006 and again in January 2008, based on results of an epidemiologic study that found that users of the birth control patch were exposed to 60% more estrogen than users of a typical COC containing 35 mcg estrogen and were twice as likely to develop blood clots.[24,25] A 2007 postmarketing study of women aged 15 to 44 years confirmed earlier studies that women in this age group were at greater risk for VTE.[26] Despite the increased overall exposure to estrogen, the peak concentration of estrogen to which women are exposed is about 25% less with Ortho Evra than with typical COCs.[24]

The FDA recommends that women with risk factors for VTE ( Table 3 ) discuss the use of the Ortho Evra patch with their HCP and consider using nonhormonal contraceptive methods instead. Women who are immobilized due to surgery or injury should discontinue the patch while they are recovering from the event.[27]

PCHRG filed a petition with the FDA in May 2008, requesting withdrawal of Ortho Evra from the market due to safety concerns based on the abovementioned studies.[28] PCHRG suggested that the FDA phase out sale of the patch over six months, allowing existing users to obtain refills while switching to another contraceptive.[28] Use of the patch has decreased in recent years, most likely due to the reports of risk of thromboembolism. Last year, about 2.7 million prescriptions were written for the patch, down from more than 9.9 million prescriptions in 2004, according to data cited by the petition.[28]

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