676 "adverse events" reported

FDA Heightens Abortion Pill Warning After Latest RU486 Patient Death

By Randall K. O'Bannon, Ph.D.
NRL Director of Education & Research

On the heels of the revelation of yet another death of a woman who took RU486, the abortion pill's U.S. distributor has sent warnings to emergency rooms and the U.S. Food and Drug Administration (FDA) has decided to beef up the warning label on the abortion pill.

This latest reported death of an American woman brings to eight the number of known deaths worldwide associated RU486. Three of those fatalities have been in the U.S. since the drug was approved for marketing in the United States in September 2000.

Few details are available on the most recent death. One news service (UPI, 11/16/04) identified the victim as a woman from New Jersey, while another news account (NY Times, 11/15/04) called her a "California woman." Accounts appear to converge on the fact that she died in January 2004 of a septic infection which followed her chemical abortion. A coroner's mistake - - identifying a different drug, methotrexate, rather than mifepristone (RU486) as the abortive agent - - delayed its report to the FDA until September.

Following a series of discussions between the FDA and Danco, the abortion pill's U.S. distributor, the "black box" warning on the drug's official label was significantly expanded. Danco also sent warning letters to potentially prescribing "health care professionals" and to emergency room directors who might end up treating complications brought on by the pill and the accompanying prostaglandin (PG) that is used to begin contractions to expel the dead unborn baby.1

Every "successful" RU486/PG abortion involves a fair amount of bleeding, pain, and cramping as the baby is killed and then expelled from the uterus. Side effects such as vomiting, diarrhea, and other forms of gastro-intestinal distress are not uncommon. At issue in the letters and labeling changes are concerns that signs of infection, ectopic pregnancies, or hemorrhaging will be masked by the chemical abortion process so that patients do not seek or receive medical care until it is too late.2

An Expanded "Black Box" and Warning Letters

The new greatly expanded "black box warning" which heads the label warns prescribers, "Serious and sometimes fatal infections and bleeding occur very rarely following spontaneous, surgical, and medical abortions, including following Mifeprex use" ["Mifeprex" is the U.S. trade name for mifepristone]. Prescribers are instructed to tell patients of these risks and to instruct them where to go and what to do if they experience "sustained fever, severe abdominal pain, prolonged heavy bleeding, or syncope [fainting]."

The new black box warns prescribers that patients can have serious infections without having fevers or displaying signs of infection in a blood test or pelvic exam. It warns, "A high index of suspicion is needed to rule out sepsis [e.g., the presence of bacteria or bacterial toxins in the blood or tissues]."

The revised label instructs prescribers to tell patients to seek immediate medical attention if they experience heavy vaginal bleeding. It also says they should advise patients to take their official medication guides with them if they visit the emergency room or another doctor.

Additional material on bleeding and infection have also been added to the standard warning section, as well as a new caution regarding ectopic (or tubal) pregnancy, whose symptoms also mirror chemical abortion's side effects. Prescribers are warned that the presence of an ectopic pregnancy may be missed even if the patient had an ultrasound prior to receiving the pills.

The letters to doctors and emergency room personnel largely repeat these labeling additions, though emphasizing diagnosis and treatment issues.

Other Deaths and Complications

In a document titled "Mifepristone Questions and Answers," the FDA reveals that some 676 "adverse events" have been reported to the agency. In that group were 72 women who bled so much they required transfusions, 17 who experienced ectopic pregnancies, and seven who dealt with serious bacterial infections. Three of those women died - - two from infections, one from a ruptured ectopic pregnancy.

In September 2001, Brenda Vise, a pharmaceutical rep from Chattanooga, Tennessee, was the first American RU486 patient to die when her ectopic pregnancy ruptured.

Holly Patterson, an 18-year-old from Livermore, California, died of a massive infection in September 2003, within a week of taking the abortion pill at an area Planned Parenthood.

Holly appears to have been killed by the same bacterial strain that took the life of a Canadian woman who participated in trials of the abortion drug there (Contra Costa Times, 11/17/04). Something similar appears to have happened in the case of the latest American fatality.

A Swedish teen bled to death in June 2003 after receiving RU486 at her local hospital. Two British women died after taking mifepristone, but details were never released by the British government. A mother of nine who took the drug died of a heart attack in the early 1990s in France.3

Impact of Heightened Warnings

Publicly, advocates of the abortion pill say they support the new warnings, but they worry how those warnings may impact demand.

Vanessa Cullins, vice president for medical affairs at the Planned Parenthood Federation of America, the nation's largest abortion chain and a major RU486 promoter, told the San Francisco Chronicle (11/16/04) that she considered the new warning label an appropriate step. However, she also said, "It's my hope this information will not scare women away who really want to try this option." To the Chicago Tribune (11/17/04), Cullins added, "All of us need to understand that no procedure, no medication is risk free."

Despite his contention that the RU486 abortion "is still a very safe procedure," Todd Griffin, obstetrics and gynecology residency director at Stony Brook University Hospital on Long Island, told the New York Post (11/21/04), "I'm sure for the next six months, people will be coming in saying 'I don't want to do that - - people are dying.'"

Monty Patterson, the father of Holly Patterson, indicated he was pleased that the FDA added the new black box warning, but said it wasn't enough (Washington Times, 11/17/04). "It's not safe," Patterson told the Contra Costa Times (11/17/04). "It killed Holly, and it's killed other women too. The question is, How many deaths are enough?"

Patterson believes the FDA should pull the drug off the market.

This may not be the last action the FDA takes regarding the abortion pill. As it gains more data, the FDA could decide to add more restrictions or to withdraw the pill from the market entirely. The closing line of its 11/15/04 statement declares unequivocally that the "FDA will continue to monitor the usage of Mifeprex and may take further action."

NOTES:

1. Every RU486 abortion involves at least two drugs: RU486, or mifepristone, which shuts down the baby's life support system, and misoprostol, a prostaglandin which is given two days later to stimulate powerful uterine contractions to expel the emaciated corpse.

2. The letters, the new label, and other documents may be viewed on the FDA web site at http://www.fda.gov/cder/drug/infopage/mifepristone/default.htm.

3. For more details on the deaths preceding this latest one, download the factsheet at www.nrlc.org.