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Investigating, Issues Public Health Advisory on Abortion Pill: Two More Deaths of RU486 Patients Revealed.

Two additional deaths in California, recently reported by the U.S. distributor of RU486, brings to 10 the number of known deaths associated with use of the drug worldwide.

According to a Los Angeles Times investigation (8/15/05), the latest to die was Orianne Shevin, a 34-year-old attorney and mother of two young children from Sherman Oaks, California. Her death from sepsis, a blood infection, on June 14 is one of those currently under investigation by the Food and Drug Administration (FDA). The name and circumstances of the other new death have not been revealed.

Dr. Steven Galson, acting director of the FDA's Center for Drug Evaluation and Research, told the New York Times (7/20/05) that five women in the United States have now died after taking abortion pills. Four of them most likely suffered lethal bacterial infections, according to the Times.

The numbers of deaths and near-deaths may be much higher than reported. The Los Angeles Times points out that while reporting deaths and side effects is mandatory for drug makers, it is voluntary for doctors. Generally, the FDA estimates that only about 10% of problems with drugs are reported, according to the newspaper.

In the United States, RU486 has been approved by the FDA to induce abortions up to 49 days. Danco, the U.S. distributor, says more than 460,000 U.S. women1 have taken Mifeprex (the trade name for RU486) since the FDA approved its use in September 2000.

Noting that bacterial infection was involved in several of the recent deaths, the FDA issued a public health advisory and indicated the agency was investigating "recently reported serious adverse events" associated with the drug.

In a press release dated July 18, 2005, Danco announced that it was revising its Mifeprex label. It will now include "updated safety information" relating to five deaths from "serious bacterial infection and sepsis" that had occurred among users of the abortion pill and its accompanying prostaglandin2 since September 2000. One of the cases occurred in Canada in 2001, while the other four came from Californiatwo in late 2003, one in early 2004, and another in mid-2005.

Five other known deaths associated with the drug were not addressed in the latest round of releases from Danco and the FDA.

Those include Brenda Vise, a Tennessee woman who died of an undetected tubal pregnancy which ruptured in September 2001; Rebecca Tell Berg, the Swedish teen who bled to death in June 2003; Nadine Walkowiak, the French mother of nine who died of a heart attack in 1991; and two unnamed women who died in Britain after taking the pills. (Details available in the NRL Educational Trust Fund factsheet "Deaths Associated with RU-486." This can be downloaded at http://www.nrlc.org/Factsheets/FS07_RU486.pdf.)

Of the five deaths mentioned in the Danco release, NRL News reported on the death of the woman in Canada (October 2001) and the death of a 22-year-old woman in early 2004 (December 2004). The 22-year-old has since been identified by the Los Angeles Times (8/15/05) as Chanelle Bryant of Pasadena.

NRL News also devoted extensive coverage to the death of Holly Patterson, the California teen who died in September 2003 (NRL News, October 2003, November 2003, and March 2004). However, the latest Danco release indicates that at least two more California women diedone still publicly unidentified woman in late 2003 and another earlier this year, revealed by the LA Times as Ms. Shevin.

In the press release, Danco Medical Director Richard Hausknecht attributed the first three deaths to a rare bacterium named Clostridium sordellii. Medical literature says that Clostridium sordellii can enter the body through an open cut or wound, such as might be found following a surgical abortion or, as one now supposes, a chemically induced RU486 abortion, which typically involves more extensive bleeding than a surgical abortion.

Clostridium sordellii infections are "atypical," in that they may involve nausea, vomiting, diarrhea, and abdominal painall regular side effects of a chemical abortionbut no telltale rash or fever. There may also be dizziness, weakness, and falling blood pressure, which other RU486 patients have reported. However, there are no obvious external symptoms to distinguish this reaction from what women and their doctors are told to expect as part of the drug-induced abortion process.

Separate warnings issued by Danco and the FDA mention the four U.S. septic deaths. They caution health care personnel that they should have a "high" (FDA) or "elevated" (Danco) "index of suspicion" of sepsis whenever chemical abortion patients present with tachycardia (rapid heart rate) and nausea, vomiting, diarrhea, or weakness. They warn that other typical signs of infection such as fever or abdominal pain may or may not be evident.

Danco warns that a pelvic exams following abortion may not pick up on the infection (Danco "Dear Health Care Provider" letter, 7/19/05). The FDA suggests that medical personnel should give "Strong consideration" to obtaining a complete blood count to look for other signs of infection such as a high number of white blood cells ("FDA Public Health Advisory: Sepsis and Medical Abortion," 7/22/05). The label, the patient information sheet, and the medication guide for mifepristone (RU486's generic name) have all been updated to reflect the latest warnings.1

Both the FDA and Danco reemphasize the FDA-approved protocol that laid out established doses, number of office visits, and methods of administration. But only FDA statements note that the four infection-related deaths in the U.S. all involved deviations from that protocol. These changes include utilizing a reduced dose of RU486, an increased dose of the prostaglandin misoprostol, and vaginal insertion (rather than oral administration) of the prostaglandin (FDA, "Questions and Answers on Mifeprex (mifepristone)," 7/19/05).

While it is legal for physicians to use FDA-approved drugs in any way they see fit, an "off-label use," or a deviation from government-sanctioned protocols, may expose a doctor to liability, particularly if there is no substantial published medical research supporting the off-label deviation. The abortion establishment has published and promoted such studies, but the FDA has not been given any evidence it found them sufficient to alter the approved protocol (see NRL News, July 2001).

Both in its press release and its letter to health care providers, Danco takes pains to emphasize that "no causal relationship" has been established between these deaths and the use of Mifeprex and misoprostol. It also says in the letter that "no causal relationship" has been established between the off-label vaginal insertion use of misoprostol and an increased risk of infection-related death.

While the FDA agrees that no causal relationship has been established between these deaths and Mifeprex and misoprostol, it presents the issue as more of an open question. "The FDA will continue to evaluate all case reports and other information to determine if there is any causal relationship" (FDA, "Questions and Answers").

As to the vaginal self-insertion of the misoprostol rather than the oral administration, the FDA says that "[w]hile some of the modified regimens have been well described in the literature, the safety and effectiveness of the Mifeprex dosing regimens, other than the one approved by the FDA, including use of oral misoprostol tablets intravaginally, has not been established by the FDA."

Philip Darney, an often quoted abortion researcher from the University of California at San Francisco (UCSF), told the LA Times he thinks vaginal self-administration of the misoprostol may explain why the infection deaths have been seen in the U.S., where vaginal self-administration of the misoprostol is common, but not in Europe, where oral administration is the norm.

The LA Times fails to note, however, that UCSF's Center for Reproductive Health Research, of which Darney is a co-founder, actively promotes vaginal self-administration of the misoprostol in its "Early Abortion Trainer's Workbook."3

California state investigators specifically chided the clinic that gave Holly Patterson the prostaglandin to administer to herself vaginally at home. They said that the written information given Holly contained no instructions about hand washing or nail grooming prior to insertion. "These are simple measures to prevent infection," the report said (Contra Costa Times, 2/25/04).

Other theories will be investigated. In its "Public Health Advisory," the FDA indicates that it is working with the manufacturers of RU486 and misoprostol tablets to make sure that neither product was contaminated with the Clostridium sordellii bacterium. At least in its initial phases, the abortion pill was being manufactured at a Chinese plant that had been associated with production violations and the shipping of tainted drugs in the past (see NRL News, December 2000).

There are legitimate questions about whether the chemical abortion method may increase the risk of infection. The bacterium mentioned here enters through open wounds or cuts, and the chemical abortion process extends the bleeding process. Furthermore, employing vaginal self-insertion of the prostaglandin creates a new opportunity for the introduction of bacteria into this area of bleeding. An article appearing in the September 2005 issue of The Annals of Pharmacotherapy speculates that RU486 may suppress the immune system, making it more difficult for the body to fight such infections.4

Efforts to investigate the possibility of a direct causal connection are appropriate, but the basic nature of the danger posed by the drug is quite obvious. Women and doctors are told to expect bleeding, cramping, pain, nausea, diarrhea, and vomiting as part of the standard chemical abortion process. Thus, they will have difficulty recognizing when those symptoms are signs of something else, such as an infection or a ruptured tubal pregnancy.

Even if the women do eventually begin to suspect something more than the abortion is going on, that awareness may not come until after the situation has been developing for some time. Antibiotics, or some form of surgical intervention, may come too late.

"That's a real issue where the woman, a young woman, has to figure out if she's beyond these so-called normal side effects ... to serious adverse events," Holly Patterson's father Monty told the Los Angeles Times (8/15/05). "You have to figure it out, be able to call for help... . I feel the drug is not safe."

Despite heavy P.R. and advertising by the abortion industry that this new chemically induced abortion method was simple and safe, the true nature of this deadly drug has gradually been exposed as one maternal death after another has been revealed, prompting many in Congress to call for the drug to be pulled from the market.5

One can only hope that these two latest deaths will help Americans realize that all abortions come with serious risks, and that there are better, safer, life-preserving, and life-affirming options for womenand their unborn babies.

Notes

1. There are reasons to believe this number may be inflated. In the past, Danco has measured usage by doses sold, rather than doses actually used. A portion of those figures was also multiplied by three to account for multiple clinics ignoring the FDA protocol and using one RU486 pill rather than the three. The RU486 pills are expensive (about $90 per pill), so reducing the dose decreases costs and increases profits.

2. For those unfamiliar with the chemical abortion process, each RU486-induced abortion involves at least two different pills and multiple steps. In the FDA-approved protocol, a woman pregnant for 49 days or less comes in, is screened, and receives the RU486 pills, which she takes in the doctor's office. This initiates the starving of the unborn child. Two days later, she returns and receives a prostaglandin, misoprostol, which initiates powerful uterine contractions to expel the tiny corpse. She will typically cramp and bleed heavily at this stage. A third visit on or about day 14 will determine whether or not the chemical abortion has been completed.

3. Available online at http://www.ansirh.org/trainingworkbook/trainingworkbook.html.

4. Ralph P. Miech, "Pathophysiology of Mifepristone-Induced Septic Shock Due to Clostridium sordellii," The Annals of Pharmacotherapy 39:9 (September 2005): 148388.

5. U.S. Senators Jim DeMint (R-S.C.) and Sam Brownback (R-Ks.) are sponsors of S. 511, the "RU-486 Suspension and Review Act," also known as "Holly's Law," which would suspend approval of the drug and require an extensive review of the pill's safety. The House version of the bill, sponsored by Rep. Roscoe Bartlett (R-Md.) is H.R. 1079. As of August 31, the bill had nine Senate and 73 House co-sponsors.
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Publication:National Right to Life News
Date:Sep 1, 2005
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