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Public Citizen, a consumer advocacy group, has launched a petition to ban the only transdermal birth control patch available in the United States after reports that it is more dangerous than oral contraceptives. The group alleges that compared to standard 35 microgram estrogen/progestin oral contraceptives, Ortho-Evra results in:
- 60 percent more estrogen on average exposure;
- greater variability in estrogen levels;
- possible two-fold increased risk of venous thrombosis
- increased risk of side effects
- 50 percent increased likelihood of discontinuation;
- no improvement in contraceptive outcomes.
Ortho-Evra is marketed in the United States by Ortho-McNeil, a pharmaceutical manufacturer based in Raritan, New Jersey, and a subsidiary of Johnson & Johnson. It is a transdermal patch applied to the skin that releases synthetic estrogen and progestin hormones to prevent pregnancy. According to the manufacturer, the patches introduce a 60 percent higher level of estrogen into the bloodstream as compared to oral contraceptives. "The patch" is applied (changed) weekly for three weeks in a row, then one week is skipped.
"If Ortho-Evra had been designed as a pill, it is unlikely to have been approved because of its increased estrogen content. The considerable safety concern of high-dose, variable estrogen exposure tips the balance of risks and benefits against the availability of Ortho-Evra as a contraceptive," Public Citizen's data-backed petition concludes.
Controversy surrounding the birth control patch was sparked after a 2005 investigation by AP found patch users suffer higher rates of life-threatening blood clots than women who take birth-control pills. Subsequent studies have found inexplicably contradicting results, and there is still much debate about its safety. U.S. sales of the patch, about 2.7 million prescriptions, totaled about $153 million in 2007.
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