More Deaths and Hospital Stays from RU-486

More Deaths and Hospital Stays from RU-486

Information has recently come to light concerning "adverse events" associated with RU-486.

Cybercast News Service (CNS) broke the story in late February, based on the FDA's response to a CNS Freedom of Information Act request. Mainstream papers ignored the bad news until April 18, when the FDA and Danco Laboratories (U.S. distributor of RU-486) issued new safety warnings.

We now learn that a woman who died from septic shock on September 1, 2001 – nine days after taking RU-486 in Canadian drug trials (see – was not the only recent fatality associated with the drug. Two additional deaths have been associated with RU-486/misoprostol. One resulted from an undiagnosed ectopic pregnancy; the other, a heart attack in a 21-year old woman with no history of heart problems.

Another patient's ectopic pregnancy was detected after taking the drugs, but fortunately in time to save her life with surgery.

Six additional women were reported to have experienced hemorrhaging so severe they required hospitalization. Serious allergic reactions also were reported in 3 women.

Danco and the FDA hastened to deny any link between the RU-486/misoprostol drug regimen and these adverse events.

RU-486 does not cause ectopic pregnancy, they explained. Of course that's true, but the side effects of RU-486/misoprostol can mask the symptoms of a ruptured ectopic pregnancy – mainly severe abdominal pain and bleeding – so that a woman may not recognize the danger she's in and seek emergency surgery immediately. About 2% of pregnancies are ectopic, and RU-486 is ineffective in aborting an ectopic pregnancy. Unless a woman seeks immediate care, she and her child may die. This is why the pro-life community objected to relaxed FDA regulations that failed to mandate using ultrasonography to rule out ectopic pregnancy, the protocol in other countries where RU-486 is available. Danco and the abortion lobby convinced the FDA to drop this requirement, perhaps because it would have added about $250-300 to the cost of RU-486 abortions.

Danco and the FDA insist that the drugs do not cause infection. True, but when they fail (8% of the time even within the prescribed 7 weeks since the last menstrual period), serious infection can be expected. The report of adverse events includes a 15-year-old patient who survived a "Life-Threatening Hospitalization." The child's symptoms included abdominal pain, adult respiratory distress syndrome, lung infiltration, pelvic pain, purulence, and septic thrombophlebitis. All this adds up to a massive, life-threatening infection.

One effect of the RU-486/misoprostol combination is to suppress the immune system. In a World Health Organization (WHO) study, 30% of women who had incomplete RU-486 abortions developed pelvic/genital tract infections due to immune system suppression. The WHO study calls for women to receive antibiotics for six weeks following an RU-486 abortion. Adverse Event Reports included a dozen "failed" or incomplete abortions, with the outcome described as "required intervention to prevent permanent impairment/damage."

Easy Access, Appalling Results

As a literary style, irony can be quite appealing. But when it comes to federal legislation, the device is beginning to wear thin. Take, for example, Sen. Tom Harkin's "Human Cloning Ban and Stem Cell Research Protection Act of 2002" (S.1893). It masquerades as a "ban" while allowing unlimited creation of human embryos by cloning, so long as all cloned embryos are killed.

The most recent example of ironically-named legislation is the "Emergency Contraception Education Act" (H.R.3887 and S.1990). Educating doctors and consumers with solid, verifiable facts about emergency contraception (EC) is about the last thing reproductive health lobbyists and sponsors intend. What the bill does is add $10 million of your tax dollars to the over $7.5 million in private foundation funds already given to market EC.

But it's not just marketing that's going on. It's the biggest disinformation campaign since population-bomber Paul Ehrlich and friends predicted that by the 1980s there'd be nothing left to eat on Earth but plankton. To be fair, Ehrlich probably believed his forecasts. Those who've snookered the public concerning EC know better. Even feminist Germaine Greer condemned "the cynical deception of millions of women by selling abortifacients as if they were contraceptives [as] incompatible with the respect due to women as human beings" (The Whole Woman, 1999).

In January 1999 the Food and Drug Administration (FDA) found numerous sales and informational materials for Preven (the first EC to gain FDA approval) to be "false or misleading, and in violation of" FDA law. The FDA chided Preven's distributor, Gynetics, for the following: 1) misleading statements or implications that Preven is an alternative to regular contraceptives; 2) misleading claims of efficacy; 3) misleading consumer ads stating "many women do not experience side effects" which, per the FDA, "minimizes the fact that there are adverse events that occur with the use of Preven"; and 4) inadequate disclosure of risk information, even in materials intended for pharmacists.

Under FDA orders Gynetics corrected these half-truths and omissions. Currently, its Preven "prescribing information" (i.e., for doctors) lists page after page of worrisome contraindications, warnings, precautions, and adverse reactions. But materials directed to consumers on the Preven website, and countless ads, brochures and fact sheets for public consumption, paint EC in much rosier hues.

CLAIM: "EC does not interrupt a pregnancy. In fact, it will not work if a woman is pregnant" ("Fact Sheet," According to the Preven website: "It takes quite a bit of time – anywhere from 8 to 10 days – for pregnancy to occur after intercourse."

FACTS: That's true only in the Newspeak of "reproductive rights" ideologues who redefine pregnancy as beginning when the 6- to 7-day-old human embryo begins implanting in the womb.

The truth is that a sperm may succeed in penetrating a secondary oocyte ("egg") within 15 to 30 minutes after intercourse, beginning the process of fertilization. From that point, conception – the fusion of their pronuclei and mingling of chromosomes to form a new unique human being – takes no more than 24 hours.

Medical textbooks uniformly define pregnancy as "the gestational process, comprising the growth and development within a woman of a new individual from conception ... to birth" (Mosby's Medical, Nursing & Allied Health Dictionary, 2002).

How does EC work? If taken pre-ovulation, EC may delay or inhibit ovulation, preventing conception; but often it does not. If taken after the LH surge which triggers ovulation, EC will not disrupt ovulation in that cycle, but can inhibit implantation of the developing embryo (causing his or her death) due to changes in the uterine lining. (See, e.g., C. Kahlenborn, MD et al., "Postfertilization Effects of Hormonal Emergency Contraception," The Annals of Pharmacology, March 2002.)

CLAIM: "EC should not be confused with Mifeprex. ... EC and Mifeprex are completely different drugs. EC helps to prevent pregnancy, while Mifeprex terminates an early pregnancy" ("Fact Sheet," supra).

FACTS: Promoters take pains to distinguish EC from RU-486, a.k.a. mifepristone or Mifeprex to distance EC in the public's mind from abortion. But, as noted, EC may also terminate an early pregnancy. And mifepristone has been used both as EC and tested as an alternative to daily contra-ceptives. And they're all used to kill young humans.

CLAIM: EC is "safer than aspirin" (Reproductive Health Technologies Project press release, Feb. 14, 2001).

FACTS: Consider this: Progestin-only EC (e.g., Plan-B) requires taking up to 50 times the usual daily dose of this hormone within a 12-hour period. Preven, and combined oral contraceptives (COC) when used as EC, require taking 4 to 8 times the usual daily COC dose within a 12 hour period. The common side effects of EC are nausea, abdominal pain, fatigue, headache, dizziness, breast tenderness, vomiting, diarrhea, and bleeding.

The Preven "Prescribing Information" warns: "Blood clots that form in the leg can cause blockage of blood flow in the leg veins [and] can travel to the lung, causing serious disability or death" ( Risks are greatly increased for women who smoke. But you won't find that in a boxed "Surgeon General's warning" on their ads.

On a pro-choice, post-abortion support message board where women discuss their experiences using EC, one finds reactions like these: "I thought I was never going to stop throwing up"; "Yuck, yuck, yuck. ... I was sick for three days"; "I'm sick. I'm sore. I'm a complete emotional wreck. I'm scared"; "i feel so many things, all so conflicting, and i have so much fear and self-loathing"; and, "FOR ME the morning-after pill was a totally negative experience which left me with lots of self-blame, unanswered questions, mistrust in doctors" (

CLAIM: Increased access to EC "will reduce the number of abortions by half" and not increase promiscuity.

FACTS: A recent government briefing paper by the Scottish Council on Human Bio-ethics demolishes that argument. EC has been readily accessible to women in Scotland for years, but abortions increased among every age group between 1990 and 1999. Teen pregnancy and abortion rates have not fallen. In Glasgow, for example, there was no drop in the abortion rate despite a 300% increase in the number of EC prescriptions.

The logic that dictates EC use will result in fewer abortions rests on an assumption that increased access to EC will not increase promiscuity. Au contraire. The Scottish Council report cites two likely causes behind the high levels both of EC use and abortion: "more unpremeditated sexual activity" and "more failures in contraception with increased use of condoms" (instead of more effective hormonal "contraceptives"). And these two factors also appear to be causing an "alarming rise" in the incidence of sexually transmitted diseases (STDs).

U.K. economist Dr. David Paton finds support for these conclusions. Investigating the impact of contraceptive access to teen pregnancy and abortion over 14 years in 16 regions of the U.K., Paton concludes there was no evidence that access to family planning reduced teen pregnancies and abortions, but to the contrary, some evidence that greater access increased teen pregnancy rates. (See, D. Paton, "The Economics of Family Planning and Underage Conceptions," Journal of Health Economics, March 2002.)

Other Risks Related to Broader EC Access

Greater access to EC by making it available over-the-counter in drug stores, on-line, and in school clinics will prevent doctors from assessing risks based on family medical history. It will also deprive doctors of an opportunity to screen and treat young women who are especially vulnerable to STDs.

Is it appropriate to link STD screening with obtaining EC? Yes, because it's not unreasonable to assume that many women seeking EC have engaged in conduct that puts them at risk for contracting an STD. One in three women seeking EC in a U.K. study admitted to having unprotected sex when they were drunk, and nearly half blamed alcohol for one-night stands they would not otherwise have had.

There are over 65 million people in the U.S. currently infected with an STD. Over 15 million new cases occur annually, one-quarter of them in people under age 20.

Many of today's top 25 STDs are incurable and/or can cause permanent damage to reproductive organs. The Medical Institute for Sexual Health reports on a recent study of 18 to 22-year-old sexually active women: 50% were infected with human papilloma virus (HPV) at some time during the 3-year study period. HPV is responsible for 99% of cervical cancers. Condoms afford little or no protection because HPV is spread by skin contact.

Greater access to EC is not a solution to the problem of "unwanted" pregnancies and abortions. Like abortion, it's a "quick fix" that takes one life and can potentially destroy another. The lies under which EC is marketed give women a false sense of safety and security, perhaps leading them to engage in conduct which puts their physical and emotional well-being at risk. The proposals for increased access will keep parents of vulnerable teens in the dark, unable to intervene to shield their daughters from the consequences of our promiscuous culture.

The best solution for the problem of "unwanted" pregnancy and rampant STDs is the one EC enthusiasts never mention: chastity. It works every time.