Abortion pill: FDA repeats warnings of risks

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Abortion pill: FDA repeats warnings of risks

Two deaths following use of the abortion pill mifepristone (Mifeprex) are under investigation.

What happened? The Food and Drug Administration (FDA) is reminding health care providers of the recommended use and risks of the abortion pill mifepristone (Mifeprex), also known as RU-486. This action follows the recent deaths of two women who had taken the abortion pill. Four previous deaths have been linked to the same drug.

Mifeprex is approved for medical abortion through the first 49 days of pregnancy. Rather than a single pill, it's a two-step process. Mifeprex is taken to block progesterone, a hormone required to sustain pregnancy. Two days later, the drug misoprostol (Cytotec) is taken to induce uterine contractions and end the pregnancy.

Both Mifeprex and misoprostol are intended to be taken by mouth. In the four confirmed deaths related to the abortion pill, Mifeprex was taken by mouth but misoprostol was inserted into the vagina. This was followed by a fatal blood infection (sepsis). In response to these deaths, the FDA added new warnings to the drug label in 2004.

A few weeks after the March 2006 reminder of the proper use of mifepristone and misoprostol, FDA determined that one of the two recent deaths was unrelated to an abortion or to the use of the two drugs. The other death remains under investigation.

What does this mean to you? Mifeprex and misoprostol are intended for oral use only. If your doctor prescribes Mifeprex and misoprostol to terminate a pregnancy, it's important to be aware of early warning signs and symptoms of a potentially life-threatening condition:

  • Abdominal pain or discomfort
  • Weakness
  • Nausea
  • Vomiting
  • Diarrhea
  • Fever or chills

If you develop any of these signs or symptoms after taking Mifeprex and misoprostol, seek immediate medical care.

Last Updated: 04/13/2006
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