FDA OKS MORNING-AFTER USE FOR PILL.
Giving women another option for preventing pregnancy, the Food and Drug Administration declared Monday that double doses of birth-control pills can be used safely and effectively as a morning-after contraceptive.
The decision was applauded by women's groups and health experts who have known for years that high doses of the drugs, taken no later than three days after unprotected sex, can serve as emergency contraceptives.
Information about the method has not been widely disseminated by the medical industry, in large part because drug manufacturers feared that promoting it would anger anti-abortion groups and increase the risk of product liability suits.
Monday's action put the federal government's official stamp of approval on the morning-after pill regimen, increasing the likelihood that more doctors and patients will use it.
Health experts believe that making emergency contraception more widely available can significantly reduce the number of unwanted pregnancies and abortions. An estimated 3.5 million unintended pregnancies occur each year in the United States, and about half of them result in abortions.
At the FDA, Deputy Commissioner Mary Pendergast warned that the method should be used only as a last-resort contraceptive because it involves a significant downside: Nausea and vomiting, sometimes severe, occur in about half of women several hours after taking the pills.
In addition, she noted that the method isn't foolproof, though it works 75 percent of time.
``This should not be the sole method of contraception,'' Pendergast said. ``We'd like to see health-care providers help women find another form of contraception they can use consistently.''
The FDA decision, published in the Federal Register along with detailed information about the morning-after pill regimen, was considered unprecedented. That's because drug makers have vigorously opposed use of their products as morning-after pills.
``The FDA has done an end-run around the companies,'' said Janet Benshoof, president of the Center for Reproductive Law and Policy, a New York-based public-interest law firm that petitioned the agency in 1994 to approve use of the morning-after pills.
Benshoof said she was delighted by the decision. ``Not only were the drug companies not asking the FDA to approve this, they were kicking and screaming for them not to,'' she said.
Supporting the petition were the American Public Health Association, American Medical Women's Association and Planned Parenthood of New York, among other groups.
The FDA and many medical experts consider the method a form of contraception because it prevents fertilization or implantation of a fertilized egg into the uterine wall.
However, the method, which has become embroiled in abortion politics, is opposed by anti-abortion groups and the Roman Catholic Church. They and others believe pregnancy begins earlier, at the moment the human egg is fertilized.
``This is another way you can abort a pregnancy,'' said Gracie Hsu, policy analyst for the Family Research Council, a conservative public policy group in Washington.
Morning-after pills are not the same as the much-publicized French abortion pill, RU-486, which is not generally used for emergency contraception. Expected to get final FDA approval later this year, the abortion pill wouldn't be taken until after pregnancy is confirmed by a doctor.
On the other hand, birth-control pills, which contain hormones that disrupt a woman's cycle, are usually taken daily. As an emergency contraceptive, a double dose - either two or four pills, depending on the brand - must be taken within 72 hours of unprotected intercourse. A second double dose is taken 12 hours after that.
The regimen has been used for 20 years in hospital emergency rooms, family planning clinics and university health centers. It has generally been used in treating rape victims or women who either neglected to use birth control or believe a condom or other contraceptive device failed.
``I think every sexually active person should have this in their medicine cabinet,'' Benshoof said.
James Trussell, director of the office of population research at Princeton University, said he believed the method would be relatively inexpensive: about $20 for the drugs and $40 for a doctor's visit.
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|Publication:||Daily News (Los Angeles, CA)|
|Date:||Feb 25, 1997|
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