Mifeprestone: a Pill That Kills
A Battleground in the War on Women
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By Denise J. Hunnell, MD
WASHINGTON, D.C., JUNE 27, (Zenit.org).- I started to feel pain in my abdomen unlike anything I had ever experienced. Then the blood came. It was gushing out of me…I sat there for hours…bleeding, throwing up into the bathroom trashcan, crying and sweating.
These are the words of Abby Johnson, former Planned Parenthood clinic director and now pro-life activist, describing her abortion using the drug RU-486, also known as mifepristone. She recovered from this horrendous ordeal after eight weeks of severe pain, bleeding and exhaustion.
Unfortunately, her experience is not unique. Even the National Abortion Federation, a pro-abortion advocacy group, admits that such side effects are the rule, not the exception, for abortions using mifepristone, commonly also referred to as medical abortions. Nausea, severe pain, heavy bleeding, diarrhea, fever and chills are part of the process. The known but less universal side effects are bleeding severe enough to require a blood transfusion, infection and/or death.
This brutal option for first trimester abortion was developed in France in the 1980s. It works by blocking progesterone, a key hormone that maintains the lining of the uterus to support the developing fetus. In 2000, the Food and Drug Administration (FDA) authorized the use of mifepristone in the United States under a fast tracked approval process normally reserved for unique life-saving therapies. This allowed the marketing of mifepristone without holding it to the usual standards of safety and efficacy. South Carolina Senator Jim DeMint soundly criticized the process:
Defining pregnancy as a life-threatening illness was a thoroughly political, not scientific, decision. Any reasonable person committed to protecting the health and safety of women should conclude that the approval process for RU-486 deserves an independent review.
Such critiques notwithstanding, there continues to be an expansion of the availability and utilization of mifepristone. The 2008 Center for Disease Control (CDC) surveillance report on abortion indicates that 14.6% of abortions were medical abortions, meaning they used mifepristone. This is in comparison to 3.4% of all abortions in 2001, the first full year after the FDA approved RU-486. By April, 2011, the FDA reported 1.52 million women in the United States had chosen to abort their children using mifepristone. Internationally, the use of mifepristone is also expanding. The United Kingdom Department of Health reported in 2009 that 40% of all abortions performed in England and Wales were accomplished using mifepristone. In Scotland, 80% of abortions done prior to nine weeks gestation and 74% of all abortions use mifepristone. Mifepristone is widely used throughout Europe with the exceptions of Ireland and Poland. It is also used extensively in Australia, New Zealand, India, China and Taiwan.
With nearly two decades of worldwide use of this abortion facient drug, what do we know about the safety and longterm effects of mifepristone? In the United States, the FDA post-marketing report of adverse events associated with mifepristone had 2,200 cases of significant side effects including blood loss requiring transfusions, serious infections, and death. It is important to note that reporting of these adverse events is entirely voluntary so they do not represent a comprehensive documentation of bad outcomes associated with mifepristone. Fourteen deaths in the United States have been linked to mifepristone. The FDA has also received reports of five mifepristone-related deaths in foreign countries. Half of these deaths were related to severe infections. In fact, of the 256 cases of mifepristone-related infections reported to the FDA, roughly 20% were deemed severe because they resulted in death, hospitalization for two or more days, or required intravenous antibiotics for at least 24 hours. A correlation between mifepristone use and infections has been detailed by Dr. Ralph P. Miech, Professor Emeritus at Brown University School of Medicine, who published an article in the Annals of Pharmacotherapy postulating that the immunosuppressant properties of mifepristone contributed to the development of septic shock in women who underwent a medical abortion.
An extensive review of adverse effects of mifepristone users in Finland was published in the October 2009 issue of Obstetrics & Gynecology. The authors reviewed the medical course of 22,368 women who underwent a medical abortion with mifepristone and 20,251 women who underwent a standard surgical abortion. The complication rate was four times higher among women who used mifepristone. A significant finding in this review was that 6.7% of women who underwent a medical abortion required further treatment because they had an incomplete abortion. This means they did not completely expel the fetus and placenta. Failure to remove this retained tissue can result in septic shock and death.
The incidence of incomplete abortion was even more pronounced in a Chinese study of mifepristone use. Published in 2011 in the Archives of Gynecology and Obstetrics, this study found that 20% of medical abortions required subsequent surgical intervention because of retained fetal tissue.
In addition to the risks of severe hemorrhage, retained fetal tissue, and life-threatening infections, a medical abortion can obscure the presence of an ectopic pregnancy, a pregnancy located outside the womb. There were 58 cases of mifepristone use with an ectopic pregnancy reported to the FDA, including two deaths. An ectopic pregnancy is a contraindication for medical abortion, but the prescribing guidelines for mifepristone do not include the routine use of ultrasound, which is the only way an ectopic pregnancy can be excluded. Unfortunately, the cramping and bleeding expected with mifepristone mimic the signs and symptoms of a ruptured ectopic pregnancy. This causes women with undiagnosed ectopic pregnancies who use mifepristone to delay seeking emergency treatment and risk death.
Clearly the potential for life-threatening complications underscores the need for mifepristone to be used under close medical supervision and with comprehensive medical follow-up. Yet this is exactly the opposite approach taken by Planned Parenthood and others seeking to make abortion more available. The National Abortion Federation reports that 87% of all counties in the United States have no abortion provider. Therefore, Planned Parenthood and other abortion advocates are seeking to bring abortion to these counties via “telemed abortions.” In this controversial procedure, a nurse or other midlevel medical practitioner examines the patient. After the initial examination, a doctor conducts a video interview of the patient, then presses a button which remotely opens a drawer containing the mifepristone and so that the patient may self-administer the mifepristone. Obviously, the doctor providing the medical abortion does not intend to deal with the potentially lethal consequences. The local medical facility and physicians that do not provide abortions are left to care for the patient with complications brought on by a medical abortion initiated by a doctor that may well be hundreds of miles away. Fortunately, five states (Arizona, Kansas, North Dakota, Nebraska, and Tennessee) have banned telemed abortions. Hopefully, more states will join them in preventing what has been termed “hit-and-run” abortions.
The loss of 1.5 million children in the United States alone through medical abortions is an unspeakable tragedy. This tragedy is compounded when the mothers of these children suffer and sometimes die from a medication that Planned Parenthood claims is natural and makes an abortion more akin to a miscarriage. The bypassing of normal FDA clinical safety trials for RU-486 and the advancement of telemed abortions in spite of the real risk of deadly complications make it clear that the abortion industry is more concerned with its own profits than it is with the health and welfare of women. Those who promote abortion, whether surgical or medical, are waging the real “war on women."
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