Last week marked the 12th anniversary of the approval for use in the United States of the abortion drug RU- 486. However, unlike other notable moments in medical history such as the discovery of penicillin in 1928 and the development of the polio vaccine in 1955, RU-486, or mifepristone, calls for a far more sobering memorial. Besides the lives purposely ended as a result of the drug, RU-486 has caused the deaths of more than a dozen women and left thousands of women with complications as a direct consequence of taking the drug.
RU-486 terminates a woman’s pregnancy over the course of several days. It works by preventing progesterone from binding to its receptors, which are located in the uterine lining. The drug blocks the receptors until the uterine lining begins to deteriorate and the embryo, deprived of oxygen and nourishment, is unable to be sustained. Two days after the mother takes RU-486, she must also take the drug misoprostol in order to expel the dead child.
An excellent analysis recently published by the Family Research Council elaborates on the side effects and safety of RU-486. The report notes that a significant study published in 2009 in Obstetrics and Gynecology (which followed women who had had surgical abortion and those who had had medical abortions) demonstrates that medical abortion had roughly four times the rate of immediate adverse effects that surgical abortion did. “20.0% of women in the medical-abortion group and 5.6% of women in the surgical-abortion group had at least one type of adverse event.” Adverse affects include hemorrhaging, infection, and incomplete abortions. Another study from Australia of RU-486 abortions taking place in the second trimester of pregnancy found that 33% of these abortions required some form of surgical intervention.
In April 2011, the Food and Drug Administration released an RU-486 Adverse Events Summary. The summary stated that since its approval some 1.52 million U.S. women have used the drug. Also by April 2011, 2,207 adverse event reports regarding RU-486 had been submitted to the FDA. These documented adverse effects of RU-486 range from the more minor to death. However, the drug is still available despite the fact that other drugs have been removed from the pharmaceutical market for risks lesser than or equal to those associated with RU-486. Sibutramine, for example, was a weight loss drug which was withdrawn by the FDA in 2010. The drug was associated with “a 16% increase in the risk for serious cardiovascular events such as nonfatal heart attack, nonfatal stroke, the need for resuscitation after the heart stopped, and death.” Sibutramine has been wisely removed from the market while RU-486 is still available and continues to take a dire toll on women’s health.
With that in mind, it is interesting that Indiana lawmakers are considering rewriting the definition of an abortion clinic to include facilities that prescribe RU-486 for abortion. Indiana is one of four states (the others being Maryland, Missouri, and Louisiana) where abortion clinic regulations are limited to facilities that perform surgical abortions. Under current Indiana law, dispensers of RU-486 are not required to be licensed as abortion providers. The issue of regulating the abortion drug is expected to be taken up in early 2013. Proposed regulations would require women taking the drug see a doctor in person due to its potentially dangerous side effects. While abortion advocates say that this will reduce access to abortion for women in rural areas, the history of RU-486 adverse event reports more than supports the wisdom of having physicians personally available to these potentially vulnerable women.