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Emergency Contraceptives in the US: Soon Available Over the Counter?

If all goes according to plan, you may not need a prescription to buy the so-called emergency contraceptive known as "the morning-after pill." One of the makers of the pill yesterday asked the US Food and Drug Administration (FDA) to approve the sale of the pill, called Plan B, over the counter. Dr. Emily Senay is here to tell us more.

On Monday, February 5, 2001, an application was made to the FDA by the makers of the morning-after pill called Plan B asking for permission to sell it over the counter. Thus emergency contraception may soon be available as a nonprescription pill. This will give women the ability to immediately terminate a potential pregnancy. The pill consists of a high dose of hormone found in birth control pills. It can be taken within 72 hours of unprotected sex to prevent the pregnancy process.

The morning-after pill (Plan B) and the abortion pill (RU- 486) are different. The abortion pill is used under the supervision of a physician after a pregnancy has been established. The morning-after pill is used to interrupt the biological events that lead to pregnancy after intercourse. So, the sooner the pill is taken after intercourse and before a pregnancy is established, the better.

What Is Emergency Contraception?

Emergency contraceptives are essentially the same thing as oral contraceptives--the same kinds of hormones as birth control pills. The difference is the dose and timing in taking the pills to prevent a pregnancy from occurring.

How Does It Work?

Plan B is made up of only one hormone--progestin. You should take it within 72 hours (3 days) after unprotected sex and then take another pill 12 hours after that. The hormone is thought to make the uterine environment inhospitable to the fertilized egg. The pill may also prevent ovulation.

If taken correctly, Plan B reduces the chance of a pregnancy by 89%. It should be taken as soon as possible after unprotected intercourse. And by the way, "morning after" is really a misnomer, because you don't have to wait until the morning after to take it.

Is the "the morning after pill" the same thing as the abortion pill--RU-486?

No. "The morning-after pill" and the abortion pill are very different. Mifeprix makes RU-486. It also is an approved pill that really is to be used after a pregnancy is established. The morning-after pill is to be used before a pregnancy has occurred.

But what if it doesn't work? Will it harm a pregnancy?

No. There are a lot of data on that, and it does not appear to have any affect on a fetus.

What about side effects?

The possible side effects are

  • Nausea and vomiting.
  • Headaches.
  • Breast tenderness.
  • Dizziness.
  • Fluid retention.
  • Fatigue and other symptoms consistent with a normal menstrual cycle.

When will this be available?

The Women's Capital Corporation, which makes Plan B, will propose two safety studies. The DA is expected to make a decision on the proposals Monday. The study results, when completed, will be submitted to the FDA in early 2002. A status change for the drug could take place in mid to late 2002.

Can you take this over and over or is it a one-time shot?

It's supposed to be a one-time shot. But you can, in the sense that it probably won't harm you. But the goal would be for women to have a regular form of birth control. And of course oral contraceptives and emergency contraceptives do not protect against sexually transmitted diseases.

How much will it cost?

Right now, as a prescription drug, it costs about $25. I think once it becomes available over the counter, it will cost about the same.

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