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FDA to Decide Status of Morning-After Pill

Agency Nears Decision on Over-the-Counter Sale of Drug Known as 'Plan B'

How Plan B Works

Women who do not want to get pregnant should use plan A first. The most effective way to avoid pregnancy is not to have sex. The next most effective way, other than permanent sterilization, is contraception. This means using barrier contraceptives such as diaphragms or condoms, IUDs, or various forms of hormonal contraception.

All these forms of contraception prevent a man's sperm from fertilizing a woman's egg. Depending on where a woman is in her menstrual cycle, emergency contraception may work the same way. But it is more likely to work after sperm fertilizes the egg.

Just as a seed isn't considered planted until it's put in fertile ground, the vast majority of doctors say a baby isn't conceived until a fertile human egg is implanted in a woman's womb. That happens about seven days after sperm and egg come together and the resulting pre-embryo travels down the fallopian tubes to the womb. Plan B keeps the fertile egg from getting planted in the womb.

If Plan B does not work -- if the egg does get planted in the womb -- the pregnancy will proceed normally, says David M. Plourd, MD, assistant professor of obstetrics and gynecology at Naval Medical Center, San Diego.

"It is an all-or-none phenomenon: With Plan B, you either don't get pregnant or you do," Plourd says. "There is no in-between. Ether it works or it doesn't. If it doesn't work, there are no effects on the pregnancy; no miscarriage and no birth defects."

How Well Does Plan B Work?

To prevent pregnancy, Plan B should be used as soon as possible after sex. That's why family planners encourage sexually active women who do not want to become pregnant to keep an emergency contraceptive in their medicine chest.

Theoretically, Plan B should work until the fertilized egg is implanted in the womb. It's been tested for up to five days, Plourd says -- but it's strongly recommended that women use it within 72 hours of sex.

If 100 women have sex one time during a single menstrual cycle -- without using any form of contraceptive -- eight of them will get pregnant.

If those same 100 women take Plan B within 72 hours of sex, two of them will become pregnant. That, Plourd says, means it's 75% effective.

"Preventing pregnancy 75% of the time is less than almost every other form of contraception," Plourd says. "That is why it is plan B, not plan A."

How Safe Is Plan B?

Julie A. Johnson, PharmD, chairwoman of the University of Florida department of pharmacy practice, was a member of the 2003 FDA advisory panel that voted to approve Plan B for over-the-counter sale.

"I've been on this committee, the Nonprescription Drug Advisory Committee, for almost four years, and I would take this to be the safest product that we have seen brought before us," Johnson said in a transcript of the panel meetings. Johnson voted with the majority for nonprescription approval.

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