Changes in label may increase childbirth use of controversial d

Sunday, July 14, 2002

Imagine an ulcer drug that for about 45 cents a dose can shorten labor in childbirth, but also helps induce abortion in women who want to end their pregnancies.

What might sound like a warped medical fantasy is actually all wrapped up in one tiny white pill called misoprostol, sold under the brand name Cytotec. Approved only to treat gastric ulcers, it's better known for obstetrical uses and has gained recent attention for its use as a labor-inducer.

Charidy Crabtree's doctor had her swallow one of these pills last October to induce labor; four hours later she gave birth to a healthy 7-pound 12-ounce boy.

She didn't know that the label warned against using it in pregnancy, and it was only later that the 22-year-old Rockford, Ohio, woman heard media reports linking Cytotec with dangerous side effects -- including deaths of women and their babies.

"I was like, 'Oh my gosh, I was given THAT?'" Crabtree said.

Obstetricians who use the drug say label changes worked out in April between the U.S. Food and Drug Administration and manufacturer Pharmacia Corp. may ease safety concerns about using the drug in labor.

Though Cytotec is still not formally approved by the FDA for obstetric use, the label, or package insert, for the first time acknowledges that it is widely used to induce childbirth.

The previous label advised against any use in pregnant women. Now it warns against using it to treat ulcers in pregnancy. It also includes a new precaution section on inducing labor and lists potentially lethal side effects, especially for women with previous Caesarean sections.

Some doctors say that's just a few steps shy of formal approval.

"If it's not the drug of choice, it is rapidly becoming that" in the United States, said Dr. Luis Sanchez-Ramos, a University of Florida obstetrics professor who has studied the drug.

'Off-label' practice

Once a drug is FDA-approved, doctors can prescribe it for conditions other than its intended purpose. This commonly used "off-label" practice is based on research or anecdotal evidence from other doctors.

Sanchez-Ramos is among obstetricians who say they prefer misoprostol as a labor-inducer because it's cheaper and more effective than drugs approved for that purpose.

More than 60 studies involving more than 6,000 patients induced with misoprostol have shown "very good results," he said.

Dr. Christian Chisholm, an assistant professor of gynecology and obstetrics at Johns Hopkins University School of Medicine, said Cytotec has many advantages over other labor-induction drugs: It can be given vaginally or orally, doesn't require an intravenous line or refrigeration, causes fewer side effects such as fever, and costs pennies compared with about $150 for some treatments.

The American College of Obstetricians and Gynecologists has endorsed its use for labor induction when used in low doses in women without previous C-sections or uterine surgery.

But obstetric associations in Canada and England say safety concerns haven't been adequately evaluated and recommend against using misoprostol to induce labor except experimentally in carefully controlled research.

The FDA says it has received 35 reports of uterine rupture and 10 infant deaths linked to Cytotec between 1988 and 2000.

When Cytotec was first used to induce labor in the early 1990s, doctors didn't know about its dangers for women with previous C-sections, Chisholm said. The C-section scar is vulnerable to the forcefulness and frequency of Cytotec-induced contractions.

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