WEDNESDAY, July 20, 2005 (HealthDay News) -- Despite U.S. health officials' warning that the so-called "abortion pill," or RU-486, may be linked to rare but potentially fatal blood infections, heath experts say the drug regimen appears to be safe.
The Food and Drug Administration issued a public health advisory Tuesday night detailing the possible risk of sepsis, or blood infection, in women using the two-drug regimen Mifeprex and misoprostol in a "manner that is not consistent with the approved labeling" to abort a pregnancy.
Misoprostol is taken two days after Mifeprex to complete an abortion. The two drugs were approved by the FDA as one regimen in September 2000.
There have been a total of four deaths in the United States, and all occurred between September 2003 and June 2005 in women who used the two-drug combination. Another woman participating in a research trial in Canada also died. All of the U.S. cases occurred in California, two in late 2003, one in early 2004 and one in mid-2005.
The rate of death amounts to about one per 100,000 users, which is "a very low level occurrence," said Dr. Paul Blumenthal, professor of obstetrics and gynecology at Johns Hopkins University in Baltimore. "That is five times lower than Viagra and it is almost exactly the same as the rate of deaths among women having surgical abortions."
Dr. Steven Galson, acting director of the FDA's Center for Drug Evaluation and Research, told the Associated Press: "There are no alarm bells going off because of this rate, but we are watching it closely."
Mifeprex has been available in the United States for almost five years and has been used by more than 460,000 women, according to the drug's maker, Danco Laboratories.
An FDA spokesperson said, "We are updating the label with the latest information, with the specifics of the bacterial infection that was seen. Sepsis was on the label before; we have now identified some of the bacteria in some of these cases."
According to a Danco statement, the bacteria in the first three cases was identified as Clostridium sordellii.
On Monday, Danco announced it was changing the drug label to incorporate the new safety details. The information will appear in an existing "black box" in the packaging. The FDA had mandated previous revisions to the label to include warnings on vaginal bleeding and ectopic pregnancy, as well as sepsis.
There is no proven cause-and-effect relationship between the drug regimen and blood infection, experts said.
"We know of nothing intrinsic in either of these two drugs [that would cause such an infection]," Blumenthal said. "Neither of these two drugs have been in the past or in any research conducted been intrinsically associated with infections at all, not to mention this specific organism which is a very unusual organism."
"But people do need to know that if something suspicious like this occurs, they should take action. They shouldn't see how they feel tomorrow," he added.
A statement released by Danco said women who use the Mifeprex and misoprostol regimen "should contact their provider or an emergency room right away if they experience abdominal pain or discomfort or general malaise... with or without fever, more than 24 hours after taking misoprostol."
The company also said it would be sending letters to physicians and emergency room directors detailing the new safety information.
"It's really important for providers to know this," Blumenthal said. "Imagine you're a woman who has taken the regimen and you do think something is awry and the closest place to go is the local emergency room. They don't programmatically prescribe these medications and they may not be familiar with some of the less likely side effects. If there is increased awareness it might increase the index of suspicion."
Dr. Vanessa Cullins is vice president for medical affairs for the Planned Parenthood Federation of America. She said, "We really hope that there's not political motivation behind the [labeling] changes. However, we all know that politics has played a role in other aspects of reproductive health.
"We do feel it is very important that women are informed of risks, however rare they might be. And it's very important for providers to also be aware of risks that they might not see on a daily basis. What has been done is responsible because it's all about educating patients and providers but it should not be sensationalized," she added.
But Wendy Wright, senior policy director for Concerned Women of America, a conservative women's group, said the label changes would not make the drug any safer, The New York Times reported.
"Changing the label the last time clearly didn't help the latest woman who died," Wright said. "Sadly, people who support RU-486 apparently believe the risk of death is preferable to having a child."
For more on the warnings and labeling changes, visit the FDA.