Monday, May 8, 2006

A grass-roots women’s group wants to ban Cytotec, a popular anti-ulcer drug used to induce labor, citing drug-related injuries and deaths for mothers and babies.

Protesters marched in the rain and held a rally yesterday outside the District’s convention center, where the 49,000-member American College of Obstetricians and Gynecologists (ACOG) is meeting this week. They are targeting ACOG because that group insists such severe outcomes are extremely rare.

“Cytotec (generic name: misoprostol) is now the standard of care for inducing labor, since it is fast and cheap. But it can cause violent contractions” and serious harm, said Maddy Oden of Oakland, Calif., both a marcher and speaker at the rally sponsored by WECAN, or Women Educating Cytotec Awareness Nationwide.

Mrs. Oden said her 32-year-old daughter, Tatia Oden French, and her daughter’s baby both died in December 2001 when Mrs. French was given Cytotec to induce labor in a “well-known and well-respected hospital.”

“My daughter had a full-term pregnancy and was totally healthy. But she was two weeks overdue, so she was given Cytotec,” Mrs. Oden said.

Cytotec is not approved by the Food and Drug Administration (FDA) to induce labor and it recommends the drug not be used by pregnant women because of the “rare but serious side effects,” such as a ruptured uterus.

Mrs. Oden describe what happened to her daughter and granddaughter: “Ten hours after being administered Cytotec, Tatia suffered hyper-stimulation of her uterus, an amniotic fluid embolism (clot) was released, an emergency C-section was performed because the baby was also in distress. Both Tatia and her baby, Zorah, died in the operating room.”

Since 2000, the FDA has issued two alerts, warning against use of Cytotec in pregnant women. In August 2000, Cytotec’s then-manufacturer, G.D. Searle & Co., warned doctors that using Cytotec to induce labor could endanger both the mother and fetus.

But on Oct. 27, 2000, ACOG took issue with Searle’s conclusions in a letter to the FDA. The professional organization said its review of adverse events reported to the FDA indicated most involved high and frequent doses of Cytotec and women with prior Caesarean delivery or major uterine surgery.

“The ACOG Committee on Obstetric Practice reaffirms that misoprostol is a safe and effective agent for cervical ripening and labor induction when used appropriately,” the group said.

The FDA issued this warning in May 2005: “There can be rare but serious side effects, including a torn uterus (womb), when mistoprostol is used for labor and delivery. A torn uterus may result in severe bleeding, having the uterus removed (hysterectomy), and death of the mother or baby.”

Early this year, Pfizer, now the manufacturers of Cytotec, also warned against its use by pregnant women.

• Researcher Amy Baskerville contributed to this report.

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