FDA
TALK PAPER

Food and Drug Administration
U.S. Department of Health and Human Services
Public Health Service 5600 Fishers Lane Rockville, MD 20857
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. 
T98-49                        Print Media:         301-827-6242
Sept. 2, 1998                 
                              Consumer Inquiries:  800-532-4440

FDA APPROVES APPLICATION FOR
PREVEN EMERGENCY CONTRACEPTIVE KIT

FDA has approved an application from Gynetics, Inc. of Belle Mead, N.J., to market "Preven Emergency Contraceptive Kit" containing oral contraceptive pills for postcoital emergency contraception packaged with a urine pregnancy test.

On the basis of its review of the medical literature, FDA has found this treatment regimen (a specific combination oral contraceptive pill consisting of ethinyl estradiol and levonorgestrel) safe and effective for pregnancy prevention in women who have had unprotected sexual intercourse. The following may be used to respond to questions.

Numerous published studies support the safety and effectiveness of certain dose regimens of oral contraceptives containing ethinyl estradiol and norgestrel or levonorgestrel when other contraceptive methods fail or when no contraception is used.

Six months ago, Gynetics Inc. submitted a new drug application for the Preven Emergency Contraceptive Kit. The Gynetics application is based on a regimen, first described by Albert Yuzpe in l974, that consists of two oral contraceptive pills (containing ethinyl estradiol and levonorgestrel) taken within 72 hours of unprotected intercourse and two pills taken 12 hours later. When used in this manner, the treatment is about 75 percent effective in preventing pregnancy. The treatment does not work if a woman is already pregnant.

Although certain oral contraceptives can currently be used "off-label" for postcoital pregnancy prevention, approval of this product allows for information on the appropriate treatment regimen to be added to the labeling for physicians and patients alike. The new product's labeling is similar to that of other oral contraceptive products. Risks, contraindications and warnings for emergency use would be similar to those for oral contraceptives prescribed for daily use.

The most common side effects related to emergency use are nausea, vomiting, menstrual irregularities, breast tenderness, headache, abdominal pain and cramps, and dizziness.

Although emergency contraception is not as effective as proper use of a regular contraceptive method, it substantially reduces the chances of becoming pregnant when used within 72 hours after unprotected sexual intercourse.

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