A life saver or life taker?

Abstract: The use of mifepristone as a non-surgical abortion method has been legal for over 11 years. Its popularity has continued to increase over time since its initial approval. But is it helping women to privately terminate unwanted pregnancies, or is it merely endangering their lives?

Introduction: On March 14, 1996, the Food and Drug Administration (FDA) approved a progesterone antagonist, mifepristone (more commonly known as RU-486 or Mifeprex), for use as an abortifacient during the first seven weeks of pregnancy. Mifepristone is an orally taken pill that blocks progesterone (a nutrient hormone that supports and feeds the developing fetus) from the fetus, starving it. The fetus is then expelled from the woman’s body. Mifepristone is one of 18 new drugs approved by the FDA in 1996, with a 54-month approval time. The application for approval was based on only two studies, which cumulatively involved a total of 4,600 women. None of these tests included adolescents. Only 92% of the trials resulted in successful abortions. These studies were of the drug’s safety and effectiveness in termination of pregnancies in the first trimester. Its initial approval included a warning that a surgical intervention may be required due to an incomplete abortion. On November 15, 2004, the FDA issued an addition to the list of warnings, bringing attention to possibly fatal complications, such as ruptured ectopic pregnancy and septic shock. On July 19, 2005, merely seven months later, the FDA reported four deaths due to sepsis in women who had used mifepristone. At this time the FDA also added to the warnings on mifepristone again, naming Clostridium sordellii as responsible for two of the deaths, noting the atypical and quite distinctive symptoms of these particular infections. It is not possible to be sure of just how many other complications have occurred in relation to mifepristone, but we do know of at least 20 near-fatal complications, including a heart attack, two cases of systematic bacterial infection and several hospitalizations for hemorrhaging.

Literature Review: The U.S. Food and Drug Administration and Center for Drug Evaluation and Research wrote “Mifeprex (mifepristone) Questions and Answers”, it was published on their web site on March 8, 2001 and updated on July 19, 2005.

The U.S. Food and Drug Administration and Center for Drug Evaluation and Research wrote “Mifepristone Medication Guide”, it was published on their website on March 8, 2001.

Dr. Fischer, Dr. Bhatnagar, Dr. Guarner, Dr. Reagan, Dr. Shieh, and Dr. Zaki, of the Centers for Disease Control and Prevention, Atlanta, Dr. Hacker, of the California Emerging Infections Program, Richmond, Dr. Van Meter, of the Alameda County Coroners Office, Oakland, CA, Dr. Iton, of the Alameda County Health Department, Oakland, CA, Dr. Poukens and Dr. Whiteman, of the Department of the Coroner, Los Angeles, Dr. Dassey, of the Department of Health Services, Los Angeles, and Dr. Cheung, of the Orange County Health Care Agency, Santa Clara, CA, wrote the article “Fatal Toxic Shock Syndrome Associated with Clostridium sordellii after Medical Abortion”, it was published in The New England Journal of Medicine in December of 2005.

Dr. Greene, of Harvard Medical School and Massachusetts General Hospital, Boston, wrote the article “Fatal Infections Associated with Mifepristone-Induced Abortion”, it was published in The New England Journal of Medicine in December of 2005.

Ms. Wright, of Concerned Women for America, wrote the article “RU-486: Killer Pills”, it was published on the Concerned Women for America website in September of 2002.

Data Analysis: Mifepristone has been controversial long before its approval in 1996. There have been countless articles, web pages, etc. about whether or not it is safe for use as an abortion method. The Concerned Women for America make many claims against mifepristone ands its manufacturers, citing that “The Population Council created Danco Laboratories to market and distribute RU-486. Danco could not find a company in the United States willing to manufacture the drug, due to the risk that healthy women would be injured or have children born with abnormalities. So it contracted with a company in China, which was previously cited by the FDA for tainted drugs.” (Wright, 2002)

The New England Journal of Medicine (NEJM) reported “four additional deaths due to C. sordellii toxic shock syndrome that occurred among previously healthy women after abortions that were medically induced with 200mg of oral mifepristone and 800 µg of vaginal misoprostol.” (Fischer, et al., 2005) This is lowest possible effective dose of mifepristone prescribed. The NEJM also compared the risk of medically induced abortion with surgical abortions performed at less than eight weeks of pregnancy. The risk of death from infection –not including any other cause– from medically induced abortions is less than 1 per 100,000 if every patient is administered the lowest dose of 200mg. Patients can be given up to three times that amount, thus increasing the risk. This appears to be a good statistic until it is contrasted with a risk of only 0.1 per 100,000 surgical abortions performed at less than eight weeks of pregnancy, the safest time during gestation to have a surgical abortion performed.

The FDA acknowledges the risk of excessive bleeding after taking mifepristone, stating that “In about 1 out of 100 women, bleeding can be so heavy that it requires a surgical procedure (curettage) to stop it.” (FDA/Center for Drug Evaluation and Research, 2001) The FDA released information concerning the restricted distribution of mifepristone, stating “Studies of mifepristone were conducted by doctors who had certain qualifications. Both the drug sponsor and the 1996 Reproductive Drug Products Advisory Committee also recommended that FDA restrict distribution of mifepristone to qualified doctors. FDA has concluded that these restrictions are necessary for the safe use of the drug.” (FDA/Center for Drug Evaluation and Research, 2005) They do not, however, readily tell patients that mifepristone was also approved under a special restricted distribution known as Subpart H. This approval process is for drugs that treat severe or life-threatening illnesses. Other drugs under Subpart H are for the treatment of cancers, etc. and can have serious side effects which are only considered within acceptable limits when the alternative is death. The FDA also did not follow their own pediatric rule, which states that any drug which can be given to adolescents must be tested on adolescents before approval. No one under 18 or over 35 was allowed to participate in the initial clinical trials, however; mifepristone is given commonly given to women outside of this age range. Some health care providers are also increasing risk to their patients. The FDA approved mifepristone for termination of pregnancy up to seven weeks, however; there are many documented cases of mifepristone being given to women up to nine weeks pregnant, including one of the four deaths mentioned earlier.

Conclusion: Regardless of personal, religious, and political standpoints on abortion, we must note the high risks associated with mifepristone and medically induced abortions. We cannot ignore both the lives that have already been lost and those that have been endangered. Women’s lives should not be jeopardized in the name of convenience. There are readily available non-invasive surgical means of pregnancy termination. Surgical abortions are relatively inexpensive, have been proven safe many times over, health care providers can be found locally to perform the surgery, and provide the same level of privacy as medical abortions. Why, then, should such a drug be left on the market to put the lives of more innocent and unknowing women at serious risk of death?

References:

FDA/Center for Drug Evaluation and Research. (2005, July 19). Mifeprex (mifepristone) Questions and Answers. Retrieved April 23, 2007, from CDER Drug Information Web site: http://www.fda.gov/cder/drug/infopage/mifepristone/mifepristone-qa.htm

FDA/Center for Drug Evaluation and Research. (2001, March 8). Mifepristone Medication Guide. Retrieved April 23, 2007, from CDER Drug Information Web site: http://www.fda.gov/cder/drug/infopage/mifepristone/medguide.htm

Fischer, M., Bhatnagar, J., Guarner, J., Reagan, S., Hacker, J. K., Van Meter, S. H., et al. (2005). Fatal Toxic Shock Syndrome Associated with Clostridium sordellii after Medical Abortion. The New England Journal of Medicine , 2352-2360.

Greene, M. F. (2005). Fatal Infections Associated with Mifepristone-Induced Abortion. The New England Journal of Medicine , 2317-2318.

Wright, W. (2002, September 10). RU-486: Killer Pills. Retrieved February 25, 2007, from Concerned Women for America: http://www.cwfa.org/articles/1561/CWA/life/index.htm

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~ by Mary Christa on October 3, 2008.

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