FDA Approves Contraceptive Ring
New birth control device will be available next year
WEDNESDAY, Oct. 3, 2001 (HealthDayNews) -- The Food and Drug Administration today announced its approval of the first hormone-releasing contraceptive implant.
NuvaRing, sold by Organon, Inc., is between 98 percent and 99 percent effective at blocking conception -- meaning that for every 100 women who use it for a year, only one or two will become pregnant, the FDA says. That rate is similar to both the birth control pill and the yet-unapproved contraceptive patch, which releases a steady stream of estrogen and progestin that offers a week of pregnancy protection.
The prescription device is a circle of soft, flexible polymer measuring 2.1 inches across. It releases a steady stream of the hormones etonogestrel and ethinyl estradiol, molecules like those found in oral contraceptives.
A woman can keep the ring in place for three consecutive weeks, removing it during the week she menstruates and replacing it with a new one after her bleeding has stopped. The device does not guard against sexually transmitted diseases.
Women with a history of blood clots, heart and vessel disease, and certain cancers shouldn't use NuvaRing. Nor is the device intended for women who smoke, because smoking can increase the risk of cardiovascular problems related to hormonal contraceptives, officials say. Side effects from the ring include vaginal discharge, vaginal infection, and irritation.
Frances DeSena, a spokeswoman for Organon, based in West Orange, N.J., says the ring will be available later this year on a limited basis through select doctors. The public launch will take place in the middle of next year.
DeSena says the pricing scheme for NuvaRing will be similar to that of other monthly contraceptives, such as the hormone injection Lunelle, marketed by Pharmacia. Lunelle runs between $30 and $50 a month, not including the price of the doctor's visit.
The NuvaRing is designed not to slip out of the vagina. If it is out for more than three hours, women should use a second form of birth control (such as a male condom or spermicide) until it has been back in place for seven days. The device may affect placement and positioning of a diaphragm, Organon says.
Dr. Regine Sitruk-Ware, executive director for contraceptive development at the Population Council, a New York City women's health group, says the new ring has at least two advantages over other hormonal birth control options. It doesn't have to be taken every day, as does the pill, which improves compliance, and women can implant it themselves, giving them a sense of control over their fertility.
"All the women in the clinical trials with the ring were very enthusiastic and wanted to continue with it," says Sitruk-Ware.
Although the ring will be released with patient-information pamphlets to help women learn how to correctly place the device, Sitruk-Ware says doctors should be sure to offer counseling to their patients who'd like to use it.
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