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Destination: Delivery / A Roadmap Through Pregnancy

T-Pump Therapy Undergoing a Close Second Look

Medications: The asthma drug terbutaline has long been used to delay early childbirth. But FDA warnings have touched off a passionate debate.


Any woman who experiences preterm labor these days may find herself smack in the midst of a rare contest of wills among several consumer health groups, each of which claims to protect women's health rights.

The issue is over the drug terbutaline and its use to quiet preterm labor via an infusion pump that can be used at home.

Terbutaline has been used by obstetricians for two decades to delay childbirth when uterine contractions begin before the 37th week of gestation--a condition that occurs in about one of every 10 births.

The medication is considered valuable, in part, because there are so few options to halt labor once it begins. Preterm labor causes at least 75% of newborn deaths that are not related to congenital malformations. Premature birth is associated with a higher risk of congenital developmental delay, visual and hearing impairment, chronic lung disease and cerebral palsy.

The problem is that terbutaline was approved by the Food and Drug Administration long ago for the treatment of asthma. And while doctors may prescribe medications for any purpose they see fit, according to a 1995 report from the American College of Obstetricians and Gynecologists, there are no scientific studies that clearly establish the effectiveness or safety of terbutaline therapy--especially the kind that women receive at home using a subcutaneous pump (sometimes called T-pump therapy).

Terbutaline is also administered orally and intravenously in a hospital.

FDA Safety Concerns

The FDA abruptly reversed its position last year and warned doctors that the safety and effectiveness of T-pump therapy at home has not been established.

The action satisfied one prominent women's health group but has outraged obstetricians and scores of families who say their babies were born healthy due to terbutaline therapy. An estimated 24,000 women received T-pump therapy from 1987 to 1993, according to Dr. Roger B. Newman, director of maternal-fetal medicine at Medical University of South Carolina. Terbutaline therapy delivered in all forms is prescribed for an estimated 260,000 pregnant women each year.

"Women are treated in the hospitals with [intravenous] terbutaline and get higher doses, and then they are sent home to lie down and cross their fingers," says Phipps Cohe, a spokeswoman with the High Risk Pregnancy Task Force, a nonprofit health group critical of the FDA's action. "We had a rush to judgment on the part of the FDA without benefit of any further scientific review of this drug."

Observers believe the FDA position rested heavily on a 1995 report from the American College of Ob-Gyn. While acknowledging that rates of preterm labor have hardly improved over the last 40 years, the statement suggested terbutaline--which is thought to relax the uterine muscles to resist contractions--is not necessarily the answer.

"Despite the widespread use . . . this approach has not been evaluated extensively, particularly in singleton gestations," the ACOG statement noted.

The statement also warned of the risk of side effects from terbutaline, which includes rapid heart rate, anxiety, nausea, insomnia, tremors, chest pain, palpitations, high blood pressure and pulmonary edema.

But fears over terbutaline may date back to 1992 when a woman pregnant with twins died suddenly while on T-pump therapy at home. The death caught the eye of the National Women's Health Network, a consumer protection group based in Washington.

The network filed a Citizen Petition to ask the FDA to alert doctors that T-pump therapy has not been shown to work and is possibly dangerous. In November 1997, the FDA concurred and notified doctors.

The FDA did not address oral terbutaline therapy or IV therapy administered in the hospital.

Still, the FDA's rebuke of the therapy has angered many doctors and patients.

"It is inappropriate to be petitioning the FDA to ban a drug and a delivery system that is believed by most obstetricians to be uniquely effective, is endorsed by numerous advocacy groups of women with high-risk pregnancies, is demanded by thousands of women who have experienced or will experience pregnancies at high risk for preterm delivery, and is clearly only rarely associated with serious cardiopulmonary effects," Newman said, in a statement posted on a Web site belonging to the Triplet Connection, a consumer group supporting women with multiple-gestation pregnancies.

Various consumer groups have joined the High Risk Pregnancy Task Force in Washington to protest the FDA action. A campaign led by Cohe's organization filed an opposing Citizen Petition in March in an effort to restore T-pump therapy. The petition is still pending, and the FDA has not commented on it.

Others Got Involved

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