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Panel backs over-the-counter 'morning-after' pill

Plan B is an emergency contraceptive that is only available by prescription in the United States.
Plan B is an emergency contraceptive that is only available by prescription in the United States.

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Advisers to the Food and Drug Administration vote to recommend emergency contraception -- or the 'morning-after' pill -- be available over the counter.
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WASHINGTON (CNN) -- Advisers to the Food and Drug Administration voted Tuesday to recommend emergency contraception -- or the "morning-after" pill -- be available over-the-counter.

The FDA generally follows the recommendations of its advisory committees, but it is not known when the agency will act on the recommendation.

The makers of the pill, known as Plan B, say that when it is taken within 72 hours of unprotected sex, it can reduce the risk of pregnancy by about 89 percent.

Plan B works several ways. It can affect the transport of sperm or eggs in the fallopian tube, preventing fertilization. It can block the surge of hormones that cause ovulation, and it also thickens the mucus in the uterus and changes the uterine lining, making it an inhospitable environment for a fertilized egg to implant.

Studies show the treatment works best when taken within 24 hours of unprotected sex. Proponents argue that if the drug were available over the counter, women would have quicker access to it, leading to reductions in unintended pregnancies and abortions.

"Over 3 million unintended pregnancies occur each year," said Dr. Carole Ben-Maimon, president of Barr Research, which is buying rights to the pill.

"With typical use, women using condoms, 15 percent of them, will become pregnant each year, and 8 percent of women using oral contraceptives will become pregnant.

"Half of the unintended pregnancies result in abortion. And again, it's estimated that up to 50 percent of these unintended pregnancies could be prevented with the use of emergency contraception."

But critics opposed to the sale of Plan B without a prescription said no studies have been done to show whether long-term use of the drug is safe.

"We're disturbed by ... lack of concern on the medical safety," said Wendy Wright of Concerned Women for America, a conservative public policy group.

"Is this safe for women, when in fact there have been no studies done on the long-term effects on women who take the morning-after pill, and there are no studies that have been done on multiple use -- if a woman uses it more than once."

Plan B is available without prescription in 31 countries and five states. In some of those locations, it isn't available as easily as aspirin but is in a category between prescription and over-the-counter drugs. A pharmacist can sell it without a prescription after consulting with the patient.

Plan B's manufacturer, Women's Capital Corp., is selling the product to Barr Laboratories Inc.

The FDA originally approved Plan B for sale by prescription in 1999, following another morning-after pill called Preven. The agency OK'd that medication in 1998.

Morning-after pills are not the same as the so-called abortion pill, RU-486. Emergency contraceptives prevent pregnancies from forming, while the abortion pill terminates the developing fertilized egg attached to the uterine wall, according to the Mayo Clinic.


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