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 PREVEN®
EMERGENCY CONTRACEPTIVE KIT Recently Became The First And Only Emergency
Contraceptive Product Approved By The FDA |
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| The FDA approved an application from Gynetics, Inc. of Belle Mead, N.J., to market "Preven® Emergency Contraceptive Kit" containing oral contraceptive pills for post-coital emergency contraception packaged with a urine pregnancy test. This treatment regimen (a specific combination oral contraceptive pill consisting of ethinyl estradiol and levonorgestrel) was found safe and effective for pregnancy prevention in women who have had unprotected sexual intercourse. It has long been known and 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. | ||||||||||||||
| The Preven® Emergency Contraceptive Kit 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. Thus, it is NOT AN ABORTIFACIENT. | ||||||||||||||
| Although certain oral contraceptives have been (for many years) and can currently be used "off-label" for post-coital 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. This 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. Emergency contraception is not as effective as proper use of a regular contraceptive method, but it substantially reduces the chances of becoming pregnant when used within 72 hours after unprotected sexual intercourse. | ||||||||||||||
| The most common side effects related to emergency use are nausea, vomiting, menstrual irregularities, breast tenderness, headache, abdominal pain and cramps, and dizziness. | ||||||||||||||
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