FDA Warns Terbutaline Poses Risk of Death in Pregnant Women

The U.S. Food and Drug Administration recently issued a safety announcement, warning 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 report explains this medication “is approved to prevent and treat bronchospasm (narrowing of airways) associated with asthma, bronchitis, and emphysema.”

In response to these risks, the FDA “is requiring the addition of a Boxed Warning and Contraindication to the terbutaline injection label to warn against this use,” the safety announcement explains. The FDA also warns against using the oral version of the drug “for prevention or any treatment of preterm labor because it has not been shown to be effective and has similar safety concerns.”

However, the announcement goes on to explain that terbutaline “is sometimes used off-label (an unapproved use) for acute obstetric uses, including treating preterm labor and treating uterine hyperstimulation.”  According to the FDA, the drug has also seen this unintended usage “over longer periods of time in an attempt to prevent recurrent preterm labor.”

Although considered “appropriate based on the healthcare professional's judgment to administer terbutaline by injection in urgent and individual obstetrical situations in a hospital setting,” the announcement explains that “the prolonged use of this drug to prevent recurrent preterm labor can result in maternal heart problems and death.” Furthermore, the report explains this drug “should not be used in the outpatient or home setting.”

The announcement explains the warning to patients comes in response to “new safety information received and reviewed by the FDA,” including “postmarketing safety reports of terbutaline used for obstetrical indications,” as well as findings published in medical journals.

The report goes on to list additional considerations, including a caution for patients who are taking the drug as intended to speak to their doctors if they become pregnant. The announcement also advises patients to contact the FDA MedWatch program directly if they experience any “adverse events involving terbutaline.”

According to the data summary, “FDA identified 12 maternal cases of serious cardiovascular events associated with use of terbutaline” after they were reported to the Adverse Event Reporting System (AERS). According to the FDA, these events, which took place between January 1, 1998 and July 2009, “included cardiac arrhythmias, myocardial infarction, pulmonary edema, hypertension, and tachycardia.”    

The announcement concludes with the assertion that “based on this information, FDA has concluded that the risk of serious adverse events outweighs any potential benefit to pregnant women receiving prolonged treatment with terbutaline injection (beyond 48-72 hours), or acute or prolonged treatment with oral terbutaline.”

Reference:

FDA Safety Announcement. (February 17, 2011) “FDA Drug Safety Communication: New warnings against use of terbutaline to treat preterm labor.” Retrieved on February 21, 2011 from the FDA