Doctors accuse drug maker of limiting abortion pill

(CNN) -- Although the controversial abortion pill was approved by the U.S. Food and Drug Administration in September, a new roadblock could be taking shape.

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Commonly known as RU-486 or mifepristone, the drug is most effective when used in combination with a second drug called misoprostol. Misoprostol has been on the market for years as a treatment for ulcers.

But physicians soon discovered it that misoprostol could be used to stop the sometimes life-threatening bleeding that can take place after a woman gives birth. It also was useful to help women in labor, and soon became a key drug for many obstetricians.

"It was safe, it was effective, it was very inexpensive," said Dr. Charles Lockwood, a fellow in the American College of Obstetricians and Gynecologists and a member of that group's committee on obstetric practice. "Very quickly, it became the agent of choice by obstetricians."

That's why it came as a surprise to many physicians when the drug's manufacturer, G.D. Searle and Co., issued a sternly worded letter titled "Important Drug Warning" concerning the use of misoprostol, marketed as Cytotec, as part of the abortion pill regimen.

The letter, which was released on August 23, just a month prior to the FDA's approval of the abortion pill, cautioned doctors that the drug was approved only for use against gastric ulcers. It also said "Cytotec administration by any route is contraindicated in women who are pregnant because it can cause abortion."

The letter continued to note other potential side effects, including uterine rupture and possible unknown effects on the future well-being of both mother and child.

At the time, ACOG responded by sending letters protesting Searle's "content, timing and tone" to the FDA and to members of Congress. ACOG questioned the company's reference to serious side effects, saying that although such consequences are possible, they are "relatively rare." The letter also hits Searle for failing "to comment on the extensive clinical experience with this agent and the large body of published reports supporting its safety" when used correctly.

To induce early abortion, the treatment involves three visits to a doctor or clinic. Following a physical exam, pregnancy test and ultrasound exam to date the pregnancy, a woman is given three mifepristone tablets to take in the office. Within two days, the woman returns to the doctor's office and takes two tablets of misoprostol.

Mifepristone blocks the hormone progesterone that's needed for a pregnancy to continue. Misoprostol causes the uterus to contract and expel the fetus. Six hours following the dose of misoprostol, most women will complete the abortion.

Bleeding or spotting can last an average of nine to 16 days. The woman returns to the doctor a third time about 12 days after getting the drugs to be sure the pregnancy has ended.

Studies published in the New England Journal of Medicine and Archives of Family Medicine in 1998 show the pill is 92 percent effective in terminating pregnancies up to 49 days in duration, or within the first seven weeks of pregnancy. If the procedure fails, the woman has a surgical abortion.

Searle's letter, however, may help to keep the treatment in limbo.

"The letter was very disturbing to the American College of Obstetricians and Gynecologists, and to the fellows," said Lockwood.

Perhaps, the ACOG official noted, Searle was anxious to avoid negative publicity.

"They felt pressure from pro-life groups," Lockwood said.

Dr. Paul Blumenthal, an associate professor in the department of gynecology at Johns Hopkins Medical Center in Baltimore, Maryland, said his hospital no longer permits the use of misoprostol in obstetrical care.

Blumenthal called Searle's letter "fear mongering" and said he thinks the result has "adversely affected the practice and the level of the standard of care of medicine in the United States."

Johns Hopkins, Blumenthal said, "many not feel that now it's worth their while, or worth the risk of exposing themselves to a potential malpractice suit, because of the implication of this letter."

Searle representatives who discussed the issue with CNN declined to comment on the record about their talks with the FDA.

However, the company vigorously defended its actions in the New England Journal of Medicine, saying the timing of its letter "was entirely coincidental." The company says its primary concern is patient safety.

Searle also said it simply reworded its labeling at the request of FDA.

FDA representatives, however, said Searle went too far, and call the new warning label misleading. The agency and the company are continuing to work on "appropriate labeling," both said.

The European version of the pill was first approved for use in September, 1988, in France. It was approved for use in Britain in 1991, and in Sweden in 1992.

It is estimated that approximately 500,000 women in Europe have had medical abortions using the pill.

CNN Medical Correspondent Rhonda Rowland and CNN.com Health Writer Michele Dula Baum contributed to this report.

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American College of Obstetricians and Gynecologists
Searle
Medline Plus: Misoprostol
Journal of the American Medical Association: Women's Health Information Center
Planned Parenthood

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