The first emergency contraceptive kit approved by the Food and Drug Administration for use after unprotected sex or birth-control failure will be shipped to distributors beginning this week and should be widely available by the end of the month.
Called the Preven Emergency Contraceptive Kit, it requires a prescription and includes higher-than-normal doses of regular birth control pills, a pregnancy test and detailed instructions. It will be stocked routinely at many Planned Parenthood clinics and major chain pharmacies, representatives say.
But pharmacists at some small independent drugstores, concerned about controlling inventory costs, say they won't stock the kits but will take special orders from customers. Women are instructed to take the pills within 72 hours of unprotected sex or birth-control failure.
Gynecologists say they will suggest sexually active women who use barrier methods of birth control or who are forgetful about using birth control consider keeping a kit on hand. The product has a shelf life of about 18 months, according to the manufacturer.
But even as women's health advocates applaud the FDA approval, they say there is more work to be done to stem the estimated 3 million unintended pregnancies and more than 800,000 abortions that occur annually in the United States.
Research is underway to improve emergency contraception. And the next push, say some doctors and public health officials, should be to make these emergency contraceptives available over the counter. Meanwhile, many women still are not aware that emergency contraception exists or mistakenly confuse it with the so-called abortion pill, which is not yet available in the U.S.
A woman who uses the kit, expected to cost about $20, will be instructed to take the pregnancy test to make sure she is not already pregnant from previous intercourse. Then she takes the first two pills, each containing a progestin (levonorgestrel) and an estrogen (ethinyl estradiol), hormones found in some brands of regular birth control pills. The second dose of two pills is taken 12 hours later.
"If a woman has not menstruated within three weeks, we recommend that she visit a doctor," says Roderick Mackenzie, president of the drug's manufacturer, Gynetics of Somerville, N.J. The regimen is about 75% effective, the company says.
The pills work, Mackenzie says, by delaying or preventing ovulation, as studies of birth control pills have proven. "There is scientific speculation that they may also work by preventing fertilization by altering the transport time of the sperm in the Fallopian tube or the egg in the Fallopian tube," Mackenzie says. "There is a theory that the pills could prevent implantation of fertilized eggs."
Mackenzie says his company has not received protests or complaints from organizations that oppose abortion. The pill won't work if a woman is already pregnant and won't affect an implanted egg, he says.
The National Right to Life Committee issued a statement saying that it has taken no position on drugs or devices that act to prevent fertilization but opposes drugs that cause an abortion.
The concept of emergency contraception has been known for decades, but the Preven kit is the first kit dedicated and labeled for this use. For years, doctors have given patients high-dose birth control pills in efforts to prevent unwanted pregnancies soon after unprotected intercourse. Then, in February 1997, the FDA publicized the formula for emergency contraception.
Since then, demand has boomed, says Nancy Sasaki, president and chief executive officer of Planned Parenthood, Los Angeles. Since the FDA publication of dose information last year, she says, "we've seen a doubling and sometimes quadrupling of emergency contraceptive use at the more than 900 Planned Parenthood clinics nationwide."
Some gynecologists say they will tell patients about the new kit.
"If I have a patient using a condom or diaphragm, I will bring it up," says Dr. William Parker, a Santa Monica gynecologist. Women who have emergency contraceptives on hand, he says, are not more inclined to neglect their regular birth control method, citing a study published in July in the New England Journal of Medicine.
With the emergency contraceptives, the severity of the side effects are highly variable. Besides nausea and vomiting, there can be menstrual cycle disturbances, breast tenderness, abdominal pain and dizziness, according to company literature.
Rosario, a 24-year-old Los Angeles college student, used emergency contraceptives after she had "spur-of-the-moment" unprotected sex with her boyfriend earlier this year. Panicked about a possible pregnancy, she went to a Planned Parenthood clinic to get the pills.
The side effects, she says, weren't that bad.
"I did feel a little nauseous," she recalls, "but I didn't throw up."
Now, research is focused on improving emergency contraception.
At Planned Parenthood of Iowa, researchers are investigating whether women could start taking the pills later than the current 72-hour limit.
Other researchers are testing levonorgestrel alone to see if side effects can be minimized and effectiveness increased, and hope to market such products by next year.
Meanwhile, the Population Council, a New York-based nonprofit organization devoted to reproductive health, holds all U.S. rights to the so-called abortion pill, RU-486, or mifeprestone. The council is working with a group of investors to get the pill on the U.S. market, says Sandra Waldman, a council spokeswoman. In May 1997, the council's contract with another company to manufacture the product was canceled, Waldman says, when the manufacturer backed out.