Dangerous Drugs:
Mifeprex / RU-486
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RU-486 / Mifeprex

On July 19, 2005, the Food and Drug Administration (FDA) issued a Public Health Advisory warning of the potential risks of using RU-486 for early pregnancy termination. The drug mifepristone, sold under the trade name Mifeprex in theU.S. , has been linked to the recent deaths of four California women. Since all of the women died of septic shock following a Mifeprex regimen, the FDA urged medical providers to suspect this condition in patients taking the drug.

On November 4, an update to the FDA's warning stated that the four septic shock victims were found to have the same type of bacterial infection. This finding lends further support to the Mifeprex-septic shock connection.

What is RU-486?

RU-486, also known as “the abortion pill”, is an artificial steroid that blocks progesterone, a hormone needed to carry a pregnancy to term. Previously used in France , RU-486 was introduced to the United States in 2000, when the Food and Drug Administration (FDA) approved its use in pill form. Since then, the abortion pill has been used by nearly half a million women in the U.S.

Mifepristone is the generic name for RU-486. In the United States , mifepristone is sold under the brand name Mifeprex®. Mifeprex is manufactured by Danco Laboratories of New York.

How is the Abortion Pill Used?

Mifeprex / RU-486 is used for the termination of early pregnancy, which is defined as 49 days or less from the first day of the last menstrual period. Because of the non-invasive nature of this drug, it is a popular choice for women who do not want to undergo a surgical abortion, or who wish to end their pregnancy privately at home rather than in a clinic. Another term often used to refer to a non-surgical abortion is “medical abortion”.

When taken alone, RU-486 causes a complete abortion only about 60% of the time. Therefore, a second drug called misoprostol, a prostaglandin, is administered to the patient 48 hours later to increase its effectiveness. Misoprostol (brand name Cytotec) causes uterine contractions, which assist in expelling the embryo from the body, therefore making the medical abortion complete. A combined mifepristone / misoprostol regimen is approximately 95-97% effective in terminating pregnancies when used as directed.

Who Should Not Use the Abortion Pill?

Women should not consider using Mifeprex / RU-486 if:

  • It has been more than 49 days (7 weeks) since their last menstrual period began.
  • They have an IUD (intra-uterine device for birth control).
  • They have been diagnosed with a pregnancy outside the uterus (ectopic pregnancy).
  • They have problems with their adrenal glands (chronic adrenal failure).
  • They take blood-thinning medication.
  • They have a bleeding problem.
  • They take certain steroid medicines.
  • They cannot return for 2 subsequent visits following the first dose of Mifeprex.
  • They cannot easily get emergency medical help in the 2 weeks after they take Mifeprex.
  • They are allergic to mifepristone, misoprostol, or medicines that contain misoprostol, such as Cytotec or Arthrotec.

What is the Procedure for a Medical Abortion?

A medical abortion using RU-486 is carried out in a series of stages. Once pregnancy is determined, a woman receives an initial dose of Mifeprex, which makes the uterine lining inhabitable for the embryo. A dose of misoprostol is taken 2 days later, which serves to terminate the pregnancy by expelling the fetus from the womb. Expulsion of the fetal tissue usually occurs 6 hours to 1 week after misoprostol is ingested.

Within two weeks of taking the dose of Mifeprex, the woman must return to her doctor's office for confirmation that the pregnancy has been properly terminated. If the pregnancy is still active, a surgical abortion must be performed.

What are the Risks Associated with Mifeprex?

Though many providers of medical abortion assert that the abortion pill is generally safe for use, concerns about the risks of Mifeprex use are rapidly growing. In late 2004, the FDA reported having received 676 "adverse event" reports concerning RU-486 abortions, including ectopic pregnancies and severe blood loss.

A more alarming risk attributed to the use of mifepristone is septic shock, or sepsis, resulting from a severe bacterial infection in the bloodstream. If left untreated, septic shock is fatal. Since 2003, several instances of death by sepsis have been associated with the use of Mifeprex.

Note - Do not change medications without first consulting your doctor.
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If you or a loved has taken Mifeprex and have undergone a hysterectomy or suffered loss of life, please fill out this form for a free evaluation of your case or call us at 1-800-275-0192 for an immediate response regarding your rights and information about compensation for injuries.

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