Women get more choices for birth control
August 24, 2006
Carolyn Westhoff runs a large federally funded family planning clinic at Columbia University.
“I see a lot of patients,” says Westhoff, a professor of obstetrics and gynecology and public health. “As many great contraceptives that we do have, we’re always interested in something new.”
Westhoff and her patients have a lot to be interested in these days. In just the past few months — after a few years in which no new contraceptives entered the market — the Food and Drug Administration gave final approval to an implantable birth control device and a new birth control pill.
The FDA also issued an “approvable letter” to the maker of another new pill, which means the agency plans to approve it as soon as the company answers some remaining questions. In addition, last fall the FDA approved a labeling change for one of the two intrauterine devices — or IUDs — on the U.S. market, expanding the pool of women who are candidates for the method.
Westhoff says her role is to make sure patients are as informed as possible about their growing number of contraceptive choices. “I don’t want to talk any woman into a particular method unless I see some particular medical issue in her situation that’s relevant.”
Implanon
Approved in July, this matchstick-sized rod is implanted under the skin of the upper arm and continuously releases progestin. Doctors are learning how to insert and remove it. Implanon should be available nationwide by early 2007.
Pros: Implanon, the only implantable contraceptive sold in the USA, frees women from thinking about birth control for three years. It was 99% effective in preventing pregnancy in clinical trials. Other progestin-only contraceptives, such as Plan B, the “morning-after pill,” don’t raise the risk of blood clots the way contraceptives containing estrogen do, and Philip Darney, obstetrics and gynecology chief at San Francisco General Hospital and consultant to Implanon’s maker, says he expects the same of Implanon.
Cons: Implantation and removal require a minor surgical procedure. Implanon releases just progestin and not estrogen, so it can cause irregular menstrual bleeding. About 11% of women quit clinical trials because of bleeding, says UCLA OB/GYN professor Anita Nelson, part of Implanon’s maker’s speakers bureau. But in 20%, periods stopped completely after a couple months’ use.
Seasonique
This new birth control pill, approved in May, became available last month. It is the next-generation version of Seasonale, the pill best known for reducing menstrual periods from once every four weeks to once every three months.
With both Seasonale and Seasonique, women take pills containing 0.15 milligrams of levonorgestrel and 0.03 mg. of ethinyl estradiol for 84 days in a row. With Seasonale, they take inactive pills for seven days between each 84-day course of active pills. With Seasonique, though, women take pills containing 0.01 mg. of ethinyl estradiol instead of inactive pills for those seven days.
Pros: As with Seasonale, Seasonique cuts annual menstrual periods to four. For many women, Carolyn Westhoff says, that’s a happy medium between monthly periods and none at all. Some women might prefer Seasonique over Seasonale because it has no inactive pills, says Westhoff, who has consulted with the makers of those pills and Implanon. “With Seasonique,” she says, “hormone levels are going to be more stable.”
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Cons: Seasonique users tend to have more vaginal bleeding or spotting between periods than do women taking pills with a 28-day treatment cycle, although such bleeding tends to decrease over time. In the main clinical trial, 82 of 1,006 women quit taking Seasonique at least partly because of bleeding.
Lybrel
According to Wyeth, its maker, this is the only pill containing its particular progestin and estrogen designed to be taken continuously, with no pill-free or placebo days. In June, Wyeth received an “approvable letter” for Lybrel from the FDA, which means that the agency has postponed approval until certain questions about manufacturing and bleeding patterns are answered. The FDA told Wyeth it will convene a meeting of contraceptive experts to discuss clinical issues related to Lybrel.
Pros: Because it’s taken every day, Wyeth says, Lybrel should even out women’s monthly hormone fluctuations. In one study reported last fall, women reported a decline in symptoms related to their menstrual cycle after just a month on Lybrel. After three months on the pill, some women in clinical trials stopped having periods.
Cons: “We know, based on our clinical trials … not all women are going to be period-free,” Wyeth spokeswoman Candace Steele says.
Paragard
Paragard is one of two intrauterine devices, or IUDs, sold in the USA. IUDs fell out of favor after one, the Dalkon Shield, was linked to miscarriage-related infections and deaths and recalled in 1975. Today’s IUDs have proven to be quite safe and effective, and they’re gaining in popularity among women too young to remember the Dalkon Shield.
Last fall, the FDA approved new labeling that promises to further hike demand. Previously, the label suggested that the optimal user had had a baby, was in a stable monogamous relationship and had never had pelvic inflammatory disease, Nelson says.
The revised label still recommends that users be in a stable relationship, but it now says that Paragard can be used by women as young as 16 who’ve never had a baby. In addition, the label now says that women with a history of sexually transmitted diseases or pelvic inflammatory disease can use Paragard. Only women who currently have acute pelvic inflammatory disease or are engaging in sexual behavior that puts them at a high risk for it should not use the IUD.
Pros: Once inserted, Paragard frees women from having to think about birth control for as long as 10 years, if they wish.
Cons: The most common side effects are heavier and longer periods and spotting between them. But these usually subside within a few months.
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