Victor R. Claveau, MJ
September 28, 2000, is a day that will be remembered as a day of infamy for those in the pro-life movement, for on this day the U.S. Food and Drug Administration approved the use of RU486.
The American Life League, led by Judie Brown, called for Congressional hearings. “The US Congress must resolve to conduct oversight hearings at once so that the FDA is held accountable for this raw, inhumane decision that will destroy babies and maim women”.[i]
Congress failed to act and the results have been as predicted. The Food and Drug Administration (FDA) on March 17, 2006 issued anotherpublic health advisory emphasizing the need for physicians and patients to be fully aware of the specific risks associated with the drug. At that time, a total of seven confirmed U.S. deaths had resulted from the RU-486 process, most due to toxic shock syndrome from the deadly bactium.[ii] Since its approval in September 2000, the Food and Drug Administration has received numerous reports of serious adverse events, including several deaths, in the United States following medical abortion with mifepristone and misoprostol.[iii]
According to Senator Jim DeMint (R), South Carolina, 10 known deaths have resulted from taking RU-486. More than 950 adverse event cases have been associated with the drug’s use.[iv] The FDA has now received reports of 1,050 additional women who experienced adverse events from the RU-486 regimen including 9 life-threatening incidents, 232 hospitalizations, 116 blood transfusions, and 88 cases of infection.[v]
Senator DeMint introduced the “RU-486 Suspension and Review Act of 2007. The bill is commonly known as “Holly’s Law,” named after 18-year-old Holly Patterson who died in 2003 from an RU-486 drug-induced abortion. According to the coroner’s report, Holly Patterson died within a week as a result of taking the drug. Senator DeMint’s legislation would suspend RU-486 from the market until the Government Accountability Office (GAO) conducts an independent review of the FDA’s approval process, which was used to declare the drug “safe and effective.” “RU-486 is a deadly pesticide that is killing pregnant women,” said DeMint. “This drug should never have been approved, and it must be suspended immediately.”[vi] Congress has yet to act on this legislation.
RU486 is the generic name of mifepristone (Mifeprex in the U.S), and is sometimes referred to as non-surgical abortion, medical abortion, or simply RU486. Non-surgical abortions using RU486 are performed in the first 63 days of the first trimester. Non-surgical abortion is usually in pill form (Mifepristone or RU486), and sometimes by injection or in liquid form (methotrexate).[vii] This medical abortion usually entails taking two pills; Mifeprex and misoprostol. Mifepristone blocks a hormone called progesterone that is needed for pregnancy to continue. It does so by binding itself to the wall of the uterus, triggering the shedding of the uterine wall and not allowing the embryo to become implanted. One or two days later, the woman takes misoprostol, which causes her cervix to soften and dilate so the embryo can be expelled. The regimen is designed to end an early pregnancy (within 49 days of the start of a woman’s last menstrual period).[viii]
The warning label on RU486 states that in clinical trials, between 4.5 percent and 7.9 percent of women required surgical intervention. Also, up to 8 percent of women experienced some type of bleeding for 30 days or more in trials.[ix] Dr. Raymond Godefroid, R.Ph., wrote, “Menstrual periods that last an average of 12 days, hemorrhage severe enough to require blood transfusion, and pain in 10% of the patients severe enough to require administration of parenteral narcotics should not be given the ‘safe’ label…The fact that premeditated pregnancy termination [abortion] is an unnatural and traumatic event, no matter what the modus operandi, makes this antiprogesterone steroid just another abortifacient…”[x]
[i] Nancy Frazier O’Brien, RU-486 approval seen as capitulation to abortion, Denver Catholic Register, Oct. 2, 2000.
[ii] http://www.fda.gov/cder/drug/advisory/mifeprex200603.htm
[iii] Mifeprex (mifepristone) Information, http://www.fda.gov/cder/drug/infopage/mifepristone/default.htm
[iv] http://nchla.org/legissectiondisplay.asp?ID=670
[v] http://demint.senate.gov/public/index.cfm?FuseAction=PressReleases.Detail&PressRelease_id=1d2231dc-277c-4ff7-b693-180d5023da88&Month=7&Year=2005&Type=Speech/Floor+Statement.
[vi] Ibid.
[vii] http://www.ru486.com/topics/articles/article_73.asp
[viii] Questions and Answerson Mifeprex (mifepristone) August, 2007, http://www.fda.gov/cder/drug/infopage/mifepristone/qa2007.htm
[ix] Mifeprex label (PDF). FDA (2005–07-19). Retrieved on 2006–08-22.
[x] Godefroid, Raymond J., R.Ph., letter in Journal of the American Medical Association, 2/16/90, p. 947.