Oct.17, 2000 -- When the FDA approved the controversial French abortion pill RU-486 (Mifeprex) last month for use in the U.S., little attention was given at first to the fact that the procedure involved not only the one drug, but two.
While Mifeprex blocks the actions of the hormone progesterone, which is needed to sustain pregnancy, a second drug, misoprostol, causes contractions and cramping of the uterus to complete the procedure. The FDA rule is that misoprostol should be taken 48 hours after the Mifeprex.
Many hailed the FDA decision as a victory for women, but some doctors say one big drawback compared with surgical abortion is this time frame, causing pill-induced abortions to be time-consuming and restrictive. Now a new study may offer a more flexible option.
The lead author of the study, appearing in Wednesday's issue of The Journal of the American Medical Association, says that by varying the FDA-approved two-drug regimen slightly and having women take the second medication vaginally instead of orally, the entire process is made more sensible and offers the woman a shorter time frame for taking the two drugs.
"The FDA has said that women have to come back two days later to get the second medication (misoprostol). If your clinic or office is not open on Saturday and Sunday, that means you can't give [the first] drug on Thursday and Friday," says Eric Schaff, MD. "[With vaginal misoprostol] if you give it on Thursday they can come back on Friday, which would be one day, or if you give it on Friday they can come back on Monday."
The 2,995 women in the study were an average of 46 days' pregnant at the time they underwent a pill-induced medical abortion. All of them took the first drug, Mifeprex, in a doctor's office or clinic and then were randomly assigned to give themselves the second drug misoprostol at home one, two, or three days later.
Doctors instructed the women to insert the four misoprostol tablets high into their vagina between 7 a.m. and midnight on the designated day. The women then returned for a follow-up visit between one and seven days after taking the misoprostol to confirm that the pregnancy had ended. If it was not, a second dose of vaginal misoprostol was given. Women underwent a surgical abortion if the pregnancy continued, if they had excessive bleeding, or if there was tissue from the pregnancy still in the uterus five weeks later.
The process was 98% effective when women took the second drug one or two days after taking the Mifeprex and 96% effective when they took the misoprostol three days later. The FDA-approved combination of Mifeprex and misoprostol, which is taken orally, is 92% to 95% effective at ending pregnancy, according to Danco, the company that distributes Mifeprex in the U.S.
Schaff says some women assigned to take misoprostol on the third day actually took it earlier than scheduled, perhaps because of anxiety. But he says as long as a woman waits at least 24 hours, but no more than 72 hours after taking the Mifeprex, the process is as effective as the FDA-approved oral regimen and causes relatively few side effects.
The most common side effect was bleeding, which began less than four hours after most women took the misoprostol. Schaff says heavy bleeding that required medical attention was rare. Nevertheless, all women were sent home with instructions to have an emergency plan to seek care if the bleeding became excessive.
"What we're showing is that there is some flexibility," says Schaff, associate professor of family medicine, pediatrics, and obstetrics and gynecology at the University of Rochester in New York.
Mitchell Creinin, MD, an associate professor and director of family planning at the University of Pittsburgh, agrees.
"She can use the misoprostol at a time that works better in her life -- when she is able to get someone to watch the kids, when she can have her partner with her, etc," says Creinin, who was not involved in the study.
"If your partner was going away in two days on a business trip, it is nice to know that you can use the misoprostol in 24 hours, when he is still there to be there with you, and not compromise [effectiveness]. Or, if you have a day off in three days and would rather wait until then, it's nice to know that you can do so," Creinin tells WebMD.
Another important thing about the new study is that the researchers included women who were up to eight weeks pregnant. The FDA has only approved pill-induced abortions for women up to seven weeks pregnant. But Schaff says his research is showing that the procedure is safe at eight, and possibly even nine weeks, which could increase the number of women who would be eligible for a pill-induced abortion.