FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available.
| T01-46 | Print Media: 301-827-6242 |
| October 3, 2001 | Consumer Inquiries: 888-INFO-FDA |
The Food and Drug Administration (FDA) today announced approval of NuvaRing
(etonogestrel and ethinyl estradiol ring), a vaginal contraceptive ring containing
a combination of estrogen and progestin hormones released from a flexible polymer
ring. The product is available by prescription only.
The vaginal contraceptive ring -- a new birth control product -- consists of a flexible, transparent, colorless vaginal ring about 2.1 inches in diameter containing the hormones etonogestrel and ethinyl estradiol, which are similar to the active ingredients in some oral contraceptives. After the ring is inserted, it releases a continuous low dose of the hormones. A new ring is used each month for continuous contraception.
The ring must be used as directed for maximum contraceptive effectiveness. A woman inserts the ring herself, and it should remain in the vagina for three weeks.
She then removes the ring for one week during which she will have her menstrual period.
Like oral contraceptives, NuvaRing is a highly effective contraceptive when used according to the labeling. Out of 100 women using NuvaRing for an entire year, one or two will become pregnant.
The manufacturer will provide a patient information brochure describing the effectiveness, benefits, and risks of the product. The patient brochure also provides information about proper use, insertion, and removal, as well as storage and disposal of NuvaRing, and also includes information about reinserting the product if it is expelled. If the ring has been out of the vagina for more than three hours, an additional method of contraception (male condom or spermicide) must be used until the ring has been back in place for seven days. NuvaRing may interfere with the correct placement and position of a diaphragm.
Other side effects of NuvaRing may include vaginal discharge, vaginitis, and irritation. Like oral contraceptives, NuvaRing may increase the risk of blood clots, heart attack, and stroke. The labeling for NuvaRing also carries the warning that cigarette smoking increases the risk of serious cardiovascular side effects from combined hormonal contraceptive use, and therefore cautions that women who use NuvaRing should be strongly advised not to smoke. Patients who have not adhered to the prescribed regimen and who have missed a menstrual period should have a pregnancy test to rule out pregnancy.
The new vaginal ring was developed by Organon, Inc., headquartered in West Orange, N.J., and NV Organon, the Netherlands. Two large multi-center trials with more than 2,300 women were conducted in the United States, Canada, Europe, and Israel. The trials evaluated the product for its acceptability, contraceptive effectiveness, and safety. Like contraceptive pills, NuvaRing is not for everyone. It should not be used by women who have cardiovascular disease, blood clots, or certain types of cancer. Women who use NuvaRing should not smoke.
By 1990, developers of the vaginal contraceptive ring were performing studies to determine the best ring size, ring material, and amount of hormones to be released.
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Office of Public Affairs
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