Drug Maker Distancing Itself From RU-486

Cytotec
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In practice, the "abortion drug", RU-486, requires the use of a second drug to be effective. RU-486 by itself interferes with the function of the lining of the uterus. This deprives the developing baby of nutrition, so he effectively starves. But by itself, it frequently is not completely effective. The developing baby frequently manages to survive, and even when he doesn't, often the mother's body fails to expel the dead body. (Having a dead body floating in her uterus can be a dangerous source of infection.) So when RU-486 was first developed in France, the makers came up with a two-drug "cocktail": the RU-486 dose is followed about two weeks later with a prostaglandin. The prostaglandin causes the mother to have contractions, which expels the dead or dying fetus.

Originally they used gemeprost or sulprostone, but these had serious side effects on the mother. (One woman died and two others suffered "cardiac events".) So they switched to an alternative drug, misoprostol. This apparently proved satisfactory, and is the drug that is intended to be used with RU-486 in the U.S.

Misoprostol was originally developed by the G. D. Searle company to help prevent gastric ulcers. The FDA approved its use for this purpose, and it is now marketed with the brand name "Cytotec".

But under U.S. law, once a drug is approved for any purpose, doctors may pretty much freely use it for other purposes. (This is called "off label" use.)

Searle has vigorously objected to the use of their product to perform abortions. Several years before the FDA approved the RU-486/Cytotec combination (March 19, 1993), Searle wrote a letter to the Wall Street Journal stating, "Searle strongly opposes any efforts to approve its use with RU486 in abortion, either in the U.S., or elsewhere."

Just weeks before the final FDA approval of RU-486 with Cytotec, Searle published a "physician alert" attempting to discourage doctors from using Cytotec to perform abortions. We reprint the text of that letter here:

August 23, 2000

Re:Cytotec (misoprostol)

IMPORTANT DRUG WARNING CONCERNING UNAPPROVED USE OF INTRAVAGINAL OR ORAL MISOPROSTOL IN PREGNANT WOMEN FOR INDUCTION OF LABOR OR ABORTION

Dear Health Care Provider:

The purpose of this letter is to remind you that Cytotec administration by any route is contraindicated in women who are pregnant because it can cause abortion. Cytotec is not approved for the induction of labor or abortion.

Cytotec is indicated for the prevention of NSAID (nonsteroidal anti-inflammatory drugs, including aspirin)-induced gastric ulcers in patients at high risk of complications from gastric ulcer, e.g., the elderly and patients with concomitant debilitating disease, as well as patients at high risk of developing gastric ulceration, such as patients with a history of ulcer.

The uterotonic effect of Cytotec is an inherent property of prostaglandin E1(PGE1), of which Cytotec is stable, orally active, synthetic analog. Searle has become aware of some instances where Cytotec, outside of its approved indication, was used as a cervical ripening agent prior to termination of pregnancy, or for induction of labor, in spite of the specific contraindications to its use during pregnancy.

Serious adverse events reported following off-label use of Cytotec in pregnant women include maternal or fetal death; uterine hyperstimulation, rupture or perforation requiring uterine surgical repair, hysterectomy or salpingo-oophorectomy; amniotic fluid embolism; severe vaginal bleeding, retained placenta, shock, fetal bradycardia and pelvic pain.

Searle has not conducted research concerning the use of Cytotec for cervical ripening prior to termination of pregnancy or for induction of labor, nor does Searle intend to study or support these uses. Therefore, Searle is unable to provide complete risk information for Cytotec when it is used for such purposes. In addition to the known and unknown acute risks to the mother and fetus, the effect of Cytotec on the later growth, development and functional maturation of the child when Cytotec is used for induction of labor or cervical ripening has not been established.

Searle promotes the use of Cytotec only for its approved indication. Please read the enclosed updated complete Prescribing Information for Cytotec.

Further information may be obtained by calling 1-800-323-4204.

Michael Cullen, MD
Medical Director, U.S.
Searle
5200 Old Orchard Road
Skokie, Illinois, 60077
Phone: (847) 982-7000
Fax: (847) 470-1480


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Posted 24 Oct 2000.

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