By Rebecca Vesely
Monday, August 1, 2005
Four women have died from blood infections in the past three years after taking the abortion pill RU-486. Now, federal investigators are examining whether other deaths or illnesses can be tied to the drug.
SAN FRANCISCO (WOMENSENEWS)--The deaths of four California women who took the abortion pill RU-486 in the past three years have spurred federal health officials to scour the country in search of more bloodstream infections that may be related to the drug.
"We're evaluating various data sources for deaths and illnesses that may have been caused by these infections," said Jennifer Marcone, spokesperson for the Centers for Disease Control and Prevention.
The investigation was announced on July 19, when the Food and Drug Administration revealed two of the deaths that occurred in 2004 and earlier this year. Previously, the agency had reported that two other California women died in 2003 after taking the abortion pill.
All four California women died of sepsis, a bloodstream infection, though they did not have the usual symptoms of an infection, such as fever, the agency said.
A day before the FDA announcement of the investigation, Danco Laboratories LLC, the manufacturer of RU-486, known under the brand name Mifeprex, announced that it was changing its labeling to include a warning for women to contact their doctor or an emergency room if they experience signs of a bacterial infection 24 hours after taking the drug.
Those signs include symptoms the women experienced, such as pain, discomfort and general malaise, including weakness, vomiting or diarrhea with or without fever.
"All of these cases had atypical presentations of infection," said Dr. Richard Hausknecht, Danco's medical director.
In the first two California cases, the bacteria were a very rare spore-forming species known as Clostridium sordelli. A Canadian woman died in 2001 during a clinical trial of Mifeprex due to the same infection. It is unknown whether this same strain of bacteria was related to the two deaths in 2004 and 2005.
Clostridium sordelli is a common soil bacterium that has shown up in a small number of obstetric and gynecological cases, including following childbirth and surgical abortion. It has been identified as a cause of pregnancy-associated toxic-shock syndrome, according to the Centers for Disease Control and Prevention. It is unknown how the women contracted the bacterial infection and that is one area the FDA and the CDC are investigating. Danco officials said that there is no evidence that Mifeprex presents a special risk of infection.
Mifeprex was approved by the FDA in 2000 to terminate a pregnancy up to 49 days after the start of a woman's last menstrual cycle. It blocks progesterone, the hormone required to carry a pregnancy to term. A second drug, misoprostol, taken 24 hours later, induces uterine contractions.
Many abortion providers instruct women to administer misoprostol at home vaginally, with clean hands, instead of following the FDA-approved protocol of taking the drug orally in a doctor's office. Federal and state health officials are investigating whether that so-called "off-label" protocol could have played a role in the deaths.
Dr. Scott Spear, chair of the national medical committee for the Planned Parenthood Federation of America, defended the protocol. "A number of regimens have shown in the literature to be safe and effective," he said. "Although these certainly are tragedies, more than a million women have taken the drug safely and effectively."
In the United States, some 460,000 women have used Mifeprex for early abortion since its approval. The drug has been used by more than a million European women as well.
Investigators are also looking at whether the pills could have somehow been contaminated or whether sexual activity after taking the drug played a role. Planned Parenthood and other providers advise women to abstain from sex for two weeks after taking the abortion protocol, Spear said.
Spear said that aside from watching closely for atypical signs of bacterial infection, Planned Parenthood is not changing they way it administers drug-induced abortions or follow-up care. "The bottom line is this is still a very safe medication," Spear said. "It's a good option for women considering terminating a pregnancy."
Holly Patterson, an 18-year-old woman from the suburbs east of San Francisco who died in 2003 after taking Mifeprex, experienced a rapid onset of infection. Patterson went to a hospital due to severe abdominal pain four days after being given Mifeprex at a local Planned Parenthood clinic. Hospital medical staff gave her painkillers and sent her home. Three days later, she went back to the hospital and died that same day.
Holly's father, Monty Patterson, says he believes that cases of infection are underreported. He is supporting "Holly's law," a bill introduced by Rep. Jim DeMint, a Republican from South Carolina, and Sen. Sam Brownback, a Republican from Kansas, that would suspend FDA approval of Mifeprex pending an audit by the General Accounting Office.
Patterson filed a wrongful death lawsuit against Danco last year and has lobbied White House and FDA officials for further investigation and an outright ban of Mifeprex.
Another question federal and state health officials are looking at why the deaths all happened in California. Besides Patterson, the names and details of the three other women have not been released. They are urging medical professionals to come forward with any cases of post-abortion or postpartum toxic shock syndrome.
"It's certainly interesting that all four cases occurred in California," Marcone said. "But right now we know of no other patterns besides geography."
Rebecca Vesely is a health care reporter at the Oakland Tribune.
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