Safety Alerts & Recalls

What does this mean?

For patients who are taking terbutaline for the narrowing of airways associated with asthma, bronchitis, and emphysema, the benefits of terbutaline will continue to outweigh the risks. However, women of child-bearing age who are taking terbutaline need to be aware of this new Boxed Warning about the risks of maternal heart problems. The FDA offers the following information to women who may be taking terbutaline:

1) Be aware that serious side effects, including maternal heart problems and death, have been reported after prolonged use of terbutaline to manage preterm labor.

2) There are serious situations where a healthcare professional may decide that the short-term use of injectable terbutaline in the hospital setting may benefit a pregnant woman.

3) Oral terbutaline should not be used either to treat or prevent preterm labor.

4) If you are taking terbutaline for another medical condition (e.g., asthma), talk to your healthcare professional if you are pregnant or become pregnant to determine whether terbutaline is still right for you.

The FDA also encourages all patients to talk to their healthcare professional if they have concerns about any treatment they are receiving. Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of their medicine to the FDA's MedWatch Adverse Event Reporting Program by telephone at 1-800-332-1088, by fax at 1-800-332-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

Terbutaline: Change To the Prescribing Information - Boxed Warning Against Use for Treatment of Preterm Labor

The U.S. Food and Drug Administration (FDA) is warning the public that injectable terbutaline should not be used in pregnant women for prevention or prolonged treatment (beyond 48-72 hours) of preterm labor in either the hospital or outpatient setting because of the potential for serious maternal heart problems and death. The agency is requiring the addition of a Boxed Warning and Contraindication to the terbutaline injection prescribing information to warn against this use. In addition, oral terbutaline should not be used for prevention or any treatment of preterm labor because it has not been shown to be effective and has similar safety concerns. The agency is requiring the addition of a Boxed Warning and Contraindication to the terbutaline tablet label to warn against this use.

Terbutaline is approved to prevent and treat bronchospasm (narrowing of airways) associated with asthma, bronchitis, and emphysema. The drug is sometimes used off-label (an unapproved use) for acute obstetric uses, including treating preterm labor and uterine hyperstimulation.

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Source: FDA
Publication Date: 2011-02-18
Last Updated: 2011-02-18

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