Misoprostol Not FDA Approved
For Use on Pregnant Women
Revelation Could Derail RU-486 Abortion Process
The Covenant News ~ October 13, 2000
In a stunning revelation that could derail the use of recently approved RU-486, the manufacturer of a drug required to be used in conjunction with the abortion pill says it has not been approved by the FDA for obstetric use.
Searle, manufacturer of misoprostol, sent a letter warning doctors not to give the drug to pregnant women. The letter was sent in August, several weeks before the Food and Drug Administration (FDA) approved RU486, National Public Radio reported Friday. Since then, misoprostol has been pulled from about half of the nation's teaching hospitals, according to an informal poll by the New York University School of Medicine.
The drug causes the uterus to contract and is often used to induce labor in full-term deliveries. It is also used to expel a fetus that has died. But it was developed as an anti-ulcer drug and has never been approved for use by pregnant women.
But it has become better known as the second drug in a regimen that causes an abortion. Mothers take RU486, which prevents the uterus from supporting a pregnancy. Then they take misoprostol, which expels the contents of the uterus.
A Question of Liability
The American College of Obstetricians and Gynecologists is protesting Searle's efforts to halt use of misoprostol. The group says randomized clinical trials have found that the drug is safe and effective when prescribed correctly. Alternatives are less effective and have troublesome side effects, NPR reported.
Among the hospitals no longer using misoprostol is the prestigious Brigham and Women's in Boston, which is affiliated with Harvard University.
"We can fully understand Searle's action in wanting to distance themselves and their drug from the RU-486 process," said a long-time Pro-Life activist. "The process is dangerous to women who choose to abort their babies and there will naturally be a great number of lawsuits filed regarding it's use."
The Covenant News has already launched a public service ad campaign to reach women who have experienced pain and suffering because they took the abortion pill RU-486. Utilizing the talents of the nation's three top post-abortion counseling and referral organizations this public service ad campaign will help women find medical attention, emotional counseling, and Medical Malpractice Attorneys.
Searle, a global leader in arthritis products and educational programs, was formerly the pharmaceutical sector of Monsanto Company. On March 31, 2000, the former Monsanto Company completed a merger transaction with Pharmacia & Upjohn, Inc. to create the Pharmacia Corporation.
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