FDA approves first emergency contraceptive kit
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Web posted at: 3:52 p.m. EDT (1952 GMT)
(CNN) -- The Food and Drug Administration has, for the first time, approved the sale and marketing of a "morning after pill," PREVEN, to prevent pregnancy.
The decision allows the pharmaceutical company, Gynetics Inc. of Somerville, New Jersey, to advertise and to sell special morning-after packets that women can keep in their medicine cabinets and use as needed.
The FDA said the drug regimen is effective 75 percent of the time. It consists of taking two oral contraceptive pills within 72 hours of unprotected sex, and another two pills 12 hours later.
Emergency contraception has been around for more than 30 years, but many women and doctors are unaware of it.
It is often confused with the so-called French abortion pill, RU-486, which actually ends a pregnancy several weeks after it has begun. But if taken correctly, the emergency contraception will not interrupt or harm an already established pregnancy.
To prevent pregnancy, the emergency contraception must be taken within three days of unprotected sex.
Until now, women and doctors put together their own emergency contraception with two, four or five birth control pills. But studies show few know about the option, especially young people.
The contraception reduces the risk of pregnancy by about 75 percent. Researchers say wide use of emergency contraception could cut unintended pregnancies and the abortion rate in half.
"We decided about six years ago that making emergency contraception widely available was the most important step we could take in the United States to reduce the incidence of unintended pregnancies," said Dr. James Trussell of Princeton University.
In February 1997, the FDA said six brands of birth control pills were safe and effective as morning-after pills, the first federal acknowledgment of the emergency birth control method that European women have been prescribed for years.
Until now, however, contraceptive manufacturers have refused to sell the form of emergency birth control here, citing litigation and political fears.
The pills prevent or delay ovulation, experts said. Some say the pills could possibly prevent a fertilized egg from implanting in the uterine wall so it can grow into an embryo.
Daisy Ayabarreno found out about emergency contraception when she started working at a New York City Planned Parenthood clinic. She ended up needing the contraception herself when her birth control failed.
"It was convenient, private, easy," she said. "There weren't too many side effects -- nothing you can't handle."
Like most patients, she experienced some nausea, dizziness and cramping.
More than 4 million women have taken emergency contraception in Britain alone, and studies there have shown no serious side effects.
Some pregnancy prevention experts are concerned women may rely on emergency contraception instead of using a standard birth control method.
"They're not effective enough for that, so you don't want to do that," said Dr. Robert Hatcher of Emory University. "You don't want the expense of it over and over again." PREVEN, available with a doctor's prescription, will be on pharmacy shelves by the end of September.
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