The FDA recently required that a black box warning be added to terbutaline, an asthma drug, because there are life-threatening risks when it is used to prevent or delay preterm labor – a use for which it was never approved. The FDA has determined that when terbutaline is used by pregnant women in a sustained effort to stave off pre-term labor, it can cause heart damage and death. According to the FDA, at least 16 pregnant women have died as a result of terbutaline since it was approved, and a dozen cases of serious cardiovascular events have been reported since the FDA first warned doctors against this unapproved use.
Clinical trials have shown that labor-suppressing drugs are ineffective after the first 72 hours. The National Women’s Health Network petitioned the FDA in 1996 asking that the agency stop the inappropriate use of terbutaline, including long-term use at home via subcutaneous pump. In response, the FDA tried educating clinicians through a series of articles and letters explaining that the drug/device combination had not been shown to work and was potentially dangerous.
Despite the evidence, terbutaline continues to be used off-label by physicians in an effort to prevent preterm labor – nearly 10,000 Ob-gyns prescribed the drug in 2010. While some of these doctors were very likely prescribing terbutaline for its approved use – to treat asthma – we know, from the women harmed, that many Obs are still using it to prevent preterm labor.
The Network is very concerned by the fact that pregnant woman are still being hurt by this ineffective drug, and we applaud the FDA’s decision to communicate directly with women by requiring a black box warning. While warning pregnant women of danger to themselves might not be enough to persuade them not to use terbutaline, we hope that the evidence that the drug just doesn’t work after the first few days will help women make an informed decision and avoid these risks.
What you can do: If you or someone you know is at risk of preterm delivery, you can review the additional resources listed below and be aware of the serious risks associated with use of terbutaline.
For the FDA Drug Safety Announcement, please click here.
For information on the NWHN’s actions, please click here.
Click here to view the American College of Obstetricians and Gynecologists (ACOG) guidelines for the management of preterm labor.
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