The U.S. Food and Drug Administration has ordered that a “black box” warning — its most serious alert — appear on the label of a drug widely used to prevent women from giving birth prematurely.
FDA officials say a recent review turned up 16 deaths of pregnant mothers using the drug, terbutaline, between 1976, when U.S. marketing of the medicine began, and 2009.
Many women receive terbutaline by injection or through a pump placed below the skin that can be operated continuously for weeks. In its safety announcement, however, the FDA urged that pregnant women not use the drug in either of those ways for “prevention or prolonged treatment” beyond 48 to 72 hours of preterm labor “because of the potential for serious maternal heart problems and death.”
In addition, terbutaline tablets should not be used at all for such treatment, the FDA said, because “it has not been shown to be effective and has similar safety concerns.”
Terbutaline was approved by the FDA to treat specific respiratory conditions. But doctors, using their latitude to recommend medicines for so-called off-label purposes, have widely prescribed it as a treatment for preterm labor.
Advocates for women carrying twins and triplets, who are at higher risk of giving birth prematurely, expressed alarm at the FDA’s decision. Terbutatline “has made a life-or-death difference for many, many of our families,” Janet Bleyl, president and founder of the Triplet Connection, a national support group, told USA Today.
The FDA’s safety concerns about terbutaline go back to 1997, when it issued a “Dear Colleague” letter to health care professionals. The “precautions” section of the labeling was then revised to warn about severe adverse reactions in pregnant women. Justifying the new strengthened warning, the FDA said it “has concluded that the risk of serious adverse events outweighs any potential benefit to pregnant women receiving prolonged treatment.”
“I hope the FDA’s new warning will help us finish the job” that got started with the 1997 letter, said Cynthia Pearson of the National Women’s Health Network, which petitioned the agency to take action in the late 1990s.
