- The Washington Times - Friday, April 19, 2002

The deaths of two women after taking the abortion pill, RU-486, has prompted the U.S. Food and Drug Administration and Danco Laboratories, the New York firm that makes the pill, to issue warning letters to physicians.
The warnings revealed that six women became seriously ill after taking RU-486, or mifepristone, and another drug, misoprostol, to end pregnancies, and two of them died.
"At this time, it is unknown whether there is a causal relationship between any of these events and the use of Mifeprex [the brand name for RU-486] and misoprostol," the FDA said in a question-and-answer area on its Web site.
But Concerned Women for America (CWA), a pro-life group that has been a fierce opponent of RU-486, immediately issued a statement blaming the abortion pill for the deaths and illnesses.
"The FDA approved RU-486 under intense political pressure, and now women are suffering the consequences. RU-486 has only one purpose: to kill a human being. Now the evidence is in that women are also victims," said CWA Senior Policy Director Wendy Wright.
As the FDA and Danco Laboratories pointed out, three women who took RU-486 in combination with misoprostol later suffered bleeding caused by a ruptured ectopic pregnancy, which occurs when a fertized egg is lodged outside the womb, often in a fallopian tube. One of those women died from a hemorrhage.
Two other women suffered severe systemic bacterial infections after taking the drugs for abortions, and one of them died.
A sixth woman, 21, had a heart attack three days after using the two-drug regimen. She recovered.
"In all of these cases, misoprostol was given vaginally, not orally, which is the approved regimen. FDA has not reviewed data on the safety and effectiveness of vaginal administration of misoprostol," the federal agency said on its Web site. Misoprostol is a prostaglandin, a type of drug that causes contractions ito help expel a fetus during an abortion.
In its April 19 "safety information" letter to health care providers, which was issued in conjunction with FDA, Danco Laboratories said it has "received a small number of reports of ruptured ectopic pregnancies" following use of Mifeprex and misoprostol.
However, Danco reminds doctors that this combination therapy is "not an effective treatment for ectopic pregnancy," meaning it is not successful in terminating such pregnancies.
"The Mifeprex label states uses of Mifeprex and misoprostol for the termination of pregnancy is contraindicated in patients with confirmed or suspected ectopic pregnancy," said the FDA.
It said ectopic pregnancies represent 2 percent of all pregnancies and are "not caused by the mifepristone and misoprostol regimen." Ectopic pregnancies "will rupture and cause bleeding" and "can be fatal," the FDA added.
But Miss Wright said CWA warned there would be heavy bleeding and other serious complications if RU-486 were approved. "We warned the public this would happen RU-486 is harmful to women. Abortion lobbyists should stop putting their political agenda above women's health and end their advocacy and distribution of RU-486."
As for the risk of serious infection, the FDA said the rate of such infection as a side effect of pregnancy is 3.5 per 1,000 pregnancies. The agency indicated infection can occur from "normally growing bacteria in the vagina, which, in rare cases, causes serious infections."
Such serious infections occur in two out of every 1,000 surgical abortions, said the FDA. "We do not know what role, if any, Mifeprex and 'off-label' use of vaginal misoprostol may have in developing serious infections," it said.
Asked whether there have been previous heart attacks in women who have used RU-486, the FDA said there have been four prior heart attacks "due to coronary spasm" one of them fatal in women in Europe who used the abortion pill in combination with prostaglandins other than misoprostol. Those drugs, the FDA said, are not approved for use in the United States.

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