Category: The Abortion Pill

Pro-Choice activists like to blame pro-lifers for delaying the approval of RU-486 in the United States, and it’s true that many pro-life organizations what it as hard as they could. But another reason that it took so long for pharmaceutical companies to start producing it had nothing to do with antiabortion pressure. Some pharmaceutical companies didn’t want to touch it because they were concerned about its effectiveness and safety.

One pharmaceutical company said that they would not produce RU-486 –

“as soon as our attorneys learn that it’s only 95% effective, they began to scream. The other 5% could involve defective children and that, in terms of liability suits, could blow us out of the water.””

Pharmaceutical company executive in the “Political History of RU-486”

Quoted in Mary E Williams. Abortion: Opposing Viewpoints (San Diego, California: Greenhaven Press, 2002)

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According to one physician

“Long-term physical effects still haven’t really been studied. For example, RU-486 crosses the blood follicle barrier and has been found in the egg follicles of women taking the drug. How this might affect future fertility, pregnancy, and the health of future children is not yet known…

As an artificial hormone, RU-486 interacts with a host of other hormone receptor sites scattered throughout the body.… Not only does RU-486 block the work of progesterone, but, because of its similar chemical structure, it also blocks the normal activity of cortisol, a hormone crucial to many of the body’s metabolic, nervous, circulatory functions. While most progesterone receptor sites are found in various organs of the female reproductive system, every tissue of the body binds cortisol, theoretically opening every system of the body to RU-486’s toxic effects.

Not only does RU-486 linger in all the body’s tissues for several days, but it is also absorbed into the cells in the area where RNA and DNA are stored. What effects this has on a woman’s DNA or RNA is unknown. But phenyl, an important part of the RU-486 molecule, is known to be toxic substance for humans.”

Tamara L Roleff. Abortion: Opposing Viewpoints (San Diego, Greenhaven Press, 1997) 153

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Danco Laboratories , the manufacturer of the abortion pill RU-486 issued this warning to emergency room doctors. Below are exerpts of the letter:

November 15, 2004

Dear Emergency Room Director:

Danco Laboratories is providing this information to assist you in taking care of patients who may present in an emergency room setting following treatment with Mifeprex ® (mifepristone) and misoprostol. In particular, you should be aware of the rare events – serious infection, prolonged heavy bleeding and ruptured ectopic pregnancy – discussed below.

There may be some women who present to an emergency room with serious and sometimes fatal infections and bleeding that occur rarely following spontaneous (miscarriage), surgical and medical abortions, including following Mifeprex use, and childbirth. A high index of suspicion is needed for timely diagnosis and intervention in these patients.

A summary of  the updated warnings follows:

Infection and Sepsis

In postmarketing experience following the use of Mifeprex and misoprostol, we have received a few reports of cases of serious bacterial infection, including very rare cases of fatal septic shock

Vaginal Bleeding

Vaginal bleeding occurs in almost all patients during the treatment procedure (see WARNINGS). According to data from the U.S. and French trials, women should expect toexperience vaginal bleeding or spotting for an average of nine to 16 days, while up to 8% of all subjects may experience some type of bleeding for 30 days or more. Prolonged heavy bleeding (soaking through two thick full-size sanitary pads per hour for two consecutive hours) may be a sign of incomplete abortion or other complications and prompt medical or surgical intervention may be needed to prevent the development of hypovolemic shock. Patients should be counseled to seek immediate medical attention if they experience prolonged heavy vaginal bleeding following a medical abortion. Excessive vaginal bleeding usually requires treatment by uterotonics, vasoconstrictor drugs, curettage, administration of saline infusions, and/or blood transfusions.

Ectopic Pregnancy

Additionally, in postmarketing experience we have received a small number of reports of ruptured ectopic pregnancy. Physicians should remain alert to the possibility that a patient who is undergoing a medical abortion could have an undiagnosed ectopic pregnancy since some of the expected symptoms of a medical abortion may be similar to those of a ruptured ectopic pregnancy. The presence of an ectopic pregnancy may have been missed even if the patient underwent ultrasonography prior to being prescribed Mifeprex.

We rely on medical feedback from health care professionals and therefore remind you to report serious adverse events and any on-going pregnancies following treatment with the Mifeprex regimen to us.

Please provide a brief clinical synopsis (by postal mail, email or phone):

Medical Director

Danco Laboratories, LLC
P.O. Box 4816
New York, NY 10185

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