Ortho Evra
January 25, 2007FDA panel okays safer, low-dose birth control
The Food and Drug Administration’s birth control advisory committee says that the agency should not put limits on the acceptable failure rate of birth control devices. The committee says that doing so would reduce the availability of contraceptives with a lower hormone dose that have other health benefits or fewer side effects.
The first birth control pills developed in the 1960s had a failure rate of about 1%. Over the last 10 years, the FDA has approved birth control pills that contain lower amounts of the hormones estrogen and progestin, but which have a more than 2% failure rate.
While these pills are less effective at preventing pregnancy, many women use them for other health reasons, such as regulating their menstrual cycle or to prevent acne. Because estrogen can cause blood clots, the lower dose contraceptives work better for these purposes, when women aren’t concerned about preventing pregnancy.
The committee also says that newer contraceptives need to be tested on women whose health and habits reflect those of the general population. The panelists said that the women who take part in clinical trials for birth control devices are usually younger, thinner and healthier than the average woman. Clinical trials that reflect the average woman’s lifestyle can give a better picture of the true safety and effectiveness of birth control devices, the panelists say.
The FDA’s examination of lower dose birth control pills comes at a time when many women are concerned about the possible side effects from the hormones in birth control. One contraceptive device, the Ortho Evra birth control patch, has been linked with side effects that include blood clots, stroke, heart attack and even death.
Research has shown that because the Ortho Evra patch releases a 60% higher dose of estrogen than birth control pills, users face three times the risk of blood clots and other Ortho Evra side effects compared with users of the pill.