FDA Okays First-Ever Marketing of

The Food and Drug Administration has approved PREVEN, a post-coital contraceptive kit that will be available for sale by prescription in late September.

Doctors and the FDA have allowed the emergency use of oral contraceptives for some time now, and European women have used emergency contraception for years. However, Gyn_tics Inc.’s PREVEN is the first product to market and package birth control pills specifically for emergency use. Fears of costly lawsuits and anti-abortion violence prompted many contraceptive manufacturers to refrain from selling “morning-after” birth control pills.

PREVEN kits consist of instructions, four oral contraceptive pills, and a pregnancy test. PREVEN is 75% effective in preventing pregnancy, but is ineffective in women who are already pregnant. Patients must take two of the kit’s four pills within 72 hours of unprotected sex. The second two pills are taken 12 hours after the first two. Side effects of PREVEN include nausea and vomiting.

Carolyn Westhoff, MD, Associate Professor of Clinical Obstetrics and Gynecology and Public Health at Columbia University said of the pills function, “The only definitive scientific evidence indicates that the birth control pills in the PREVEN Emergency Contraceptive Kit work by preventing or delaying ovulation. It has been theorized that birth control pills may also prevent fertilization of an egg, if one has been released from the ovary, or that they may produce changes in the lining of the uterus that could prevent implantation of a fertilized egg.”

Planned Parenthood will sell the kits for $20 each at its clinics.


AP and Gyn_tics Inc Press Release - September 2, 1998

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