Report: The Patch Is Safe
The world's first contraceptive patch — now awaiting U.S. government approval — is as safe and effective as the pill, and easier to remember to use, research suggests.
A study on the patch appears in Wednesday's Journal of the American Medical Association and was included in the manufacturer's application for Food and Drug Administration approval in December. The manufacturer paid for the study.
The government review of the patch, made by Johnson & Johnson's Ortho-McNeil Pharmaceutical Inc., is expected to take a year. The company also has applied for approval in Europe.
The adhesive hormone patch is about the size of a matchbook. It delivers continuous low levels of estrogen and progestin, designed, like birth control pills, to prevent ovulation. It can be worn on the abdomen or buttocks.
Three patches, each worn for a week, are used during a menstrual cycle. The user has her period in the fourth week.
The study suggests the Ortho Evra patch will offer "the promise of another safe and effective form of reversible contraception," said Dr. Paul Blumenthal, a Johns Hopkins University researcher and medical adviser to Planned Parenthood who was not involved in the research.
However, since its introduction in 1960, the pill itself has been a source of health concerns.
A report released in October, 2000, found that among sisters and daughters of women with breast cancer, users of the pill were three times more likely than nonusers to get the disease.
An earlier study found that women taking the pill were nearly twice as likely as non-users to suffer a stroke, but said that risk was outweighed by the potential benefits of the pill, since so few women of child-bearing age suffer strokes.
And people who smoke, are very obese or have a history of blood clots are at risk of stroke or other health problems if they take the pill.
According to the FDA, 10.7 million American women now use the pill, making it the most popular form of non-surgical birth control.
The new study compared results from 812 women wearing the patch versus 605 on Wyeth-Ayerst's Triphasil birth control pills for at least six cycles.
Five patch women got pregnant, compared with seven on the pill. But the difference was not considered statistically significant.
The percentage of cycles in which there was perfect compliance, meaning the method was used as directed, was nearly 90 percent in the patch women and nearly 80 percent in the pill women.
"The numerically lower overall failure rate for the contraceptive patch may be due to better compliance shown with this once-weekly dosing regimen," the researchers wrote.
Twenty percent of the patch users had skin irritations at the patch site. Other side effects were relatively common in both groups and were mostly minor, such as headaches, nausea and breast discomfort.
The price of the patch has not been determined.
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