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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 postcoital 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 hourslater. 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 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. 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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Additional Information About Preven™
and the History of Contraception
Copyright 1997-98: MJ
Bovo. All right reserved.
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