Barr Laboratories
Plan B emergency contraception is used to prevent pregnancy after unprotected sex. Allowing unrestricted access to the hormone pills could prevent as many as half of all unintended pregnancies, experts predict.
By Jane Weaver Health editor
updated 3/4/2004 6:06:01 PM ET 2004-03-04T23:06:01

Is emergency contraception safe? Does it work? Can the majority of women understand how to use it? Do the benefits outweigh the risks?

These were some of the key questions weighed by the Food and Drug Administration before putting off its decision on whether to allow the over-the-counter sale of morning after pills. Saying it needed more time to review data on use by teens, the FDA announced Feb. 13 that it was delaying its decision for up to 90 days.

Packaged doses of the concentrated hormone pills are used by women after unprotected sex, when other contraception is inadequate or as a result of sexual assault. If taken within 72 hours of sexual intercourse, the pills can reduce the chances of getting pregnant by up to 89 percent.

Doctors have been prescribing emergency contraception pills since the FDA approved their use in 1998, but despite the pills' reputation as being highly effective and safe, few women have ever taken them. Only 43 percent of women know that emergency contraception is available in the United States and only six percent of American women between 15 and 44 have ever used emergency contraception, according to a series of polls conducted by the Kaiser Family Foundation.

Drug manufacturers haven't publicized the drugs and some pharmacies, including a major chain, don't stock them, curtailing women's access to the pills. Even in the five states where the drug is available directly from a pharmacist without a doctor's prescription -- Washington, California, Alaska, Hawaii and New Mexico -- it has still been difficult for women to find a participating drug store, according to transcripts of a December FDA meeting.

Politics vs. biology
Why? When it comes to emergency contraception, it's hard to separate the political issues from the biological ones.

Video: FDA decision pending on Plan B From the medical perspective of groups like the American College of Obstetricians and Gynecologists (ACOG) and over-the-counter supporters like Dr. David Grimes of Family Health International in Durham, N.C., emergency contraception is effective and easy to use. In their view, there's no medical reason to require a woman to see a doctor before getting access to emergency contraception in order to prevent an unwanted pregnancy.

"It is extremely safe," says Grimes. "No woman has ever died or been seriously hurt by emergency contraception."

Currently there are two FDA-approved prescription emergency contraception regimens -- Preven, an estrogen and progestin combination, and Plan B, a progestin-only dosage. Each Plan B tablet contains three-quarters of a milligram of levonorgestrel, which is a synthetic progestin contained in many oral contraceptives.

The pending FDA decision applies only to Plan B from Barr Laboratories, which first sought OTC status from the FDA last April.

How the drug works
The pill works in three ways:

  • By preventing or inhibiting ovulation, or the release of an egg from a woman’s ovary.
  • By impairing sperms' ability to penetrate the egg.
  • By altering the uterine lining so that a fertilized egg — an egg that has been penetrated by a sperm -- can’t implant.

Some opponents of the morning after pill argue that because emergency contraception may prevent a fertilized egg -- their definition of the beginning of life -- from implanting in the uterus, it is akin to abortion. Others charge that young women would be more likely to practice unsafe sex if they could grab a morning after pack next to a pack of gum, prompting a rise in promiscuity and sexually transmitted diseases.

Wendy Wright, senior policy director for Concerned Women for America, a conservative public policy group, notes that marketing campaigns for Plan B are targeted to young women and seem to encourage multiple sex partners. One poster advertisement features a college soccer team, declaring, “Delta Delta Thi. 27 upstanding young men. 34 billion sneaky little sperm.”

"A young woman engaging in risky sexual activity needs to be seen by a medical expert," she says. "She is in need of counseling. She needs to be aware of putting her life in danger."

Fears of a rise in STDs such as chlamydia or gonorrhea would seem to be backed up by a recent report from the Centers for Disease Control and Prevention stating that young people aged 15 to 24 account for nearly half of all cases of sexually transmitted diseases in the United States. More than half of high school students are sexually active, statistics say. But whether or not better access to morning after pills would contribute to a further increase is still open to debate.

Advocates of emergency contraception say the claim that OTC sales of the drug will encourage promiscuity is erroneous and patronizing. Moreover, they argue, increased use of the pills could prevent millions of abortions.

"The assumption is, if women have easy access to emergency contraception, they'll run wild in the streets," says Grimes. "That's being patronizing and paternalistic to women."

Nearly 50 percent of the 6.3 million annual pregnancies in the United States are unintended due to either lack of any contraceptive method or contraceptive failure, according to ACOG research. ACOG estimates that widespread use of emergency contraception could reduce the number of unintended pregnancies by half.

The earlier the better
The earlier the medication is taken, the better it works. The morning after pill is effective up to 72 hours after sex, but probably works best if taken in the first 24 hours. The packaged doses contain two pills which women take 12 hours apart.

Side effects include nausea or vomiting, abdominal pain and fatigue, although the progestin-only Plan B tends to cause fewer problems than older versions. Some women experience irregular vaginal bleeding and others report dizziness and headaches.

If a woman is pregnant and takes the morning after pill or if the pill fails to prevent the pregnancy, research indicates that the medication will not cause harm to the fetus.

Critics of the drug such as the Concerned Women for America argue that the pill is a blast of high-dose hormones that haven’t been tested for long-term side effects, particularly on adolescent females. There's also concern that because regular birth control pills are considered too risky for non-prescription use, then morning after pills should be restricted as well.

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"Once it becomes over-the-counter, there will be women who use these high doses more often," says Wright.

Not for frequent use
Even strong advocates acknowledge that the morning after pill should not be used as a regular contraceptive, although studies indicate that a repeat of the dosage even within the same menstrual cycle doesn't cause harm.

A 1998 study published in the New England Journal of Medicine found that most women would not rely on it as a primary method of contraception and 98 percent of participants used it correctly. A forthcoming study from the University of Pittsburgh finds that women who have easier access to emergency contraception are more likely to use it, but don't abandon other methods and don't engage in riskier sex.

Although some charge that OTC emergency contraception would encourage teen promiscuity, the drug's relatively high cost would likely dissuade frequent use, others say. It currently costs as much as $30 to fill a prescription for Plan B. While the drug's maker Barr Laboratories hasn’t released expected OTC pricing, it’s been estimated that a dosage of two pills could sell for about $30, compared to an average of $8 for a package of condoms.

“At $30 to $40 a pop, how often are you going to have sex without any other contraception?” asks James Trussell, director of the Office of Population Research at Princeton University.

Even with non-prescription access to the pills, Trussell doesn't see a stampede of women rushing into pharmacies for Plan B.

"Going OTC by itself won't make much difference, except it will make it easier for women who know about it to get it and for them to get it sooner," he says. "There is tremendous potential for emergency contraception to reduce incidence of unintended pregnancy and reduce the need for abortion."

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