FDA Issues New Warnings On The Drug Terbutaline
May 25, 2011
A drug that has been used for years in mothers dealing with preterm labor now has warnings that it could cause serious heart problems or death. The U.S. Food and Drug Administation (FDA) says that the injectable version of the drug, terbutaline, should not be used for the prolonged treatment of preterm labor in a hospital or outpatient setting.
The drug is approved to prevent and treat bronchospasms (the narrowing of airways) in asthma, bronchitis, and emphysema patients; however, it has been used “off-label,” meaning an unapproved use, for acute obstetric conditions such as preterm labor and uterine hyperstimulation. Serious problems have been proven to arise in patients who used the drug for extended periods to prevent recurring preterm labor.
Studies have shown that sixteen maternal deaths have occurred since 1976 in association with the drug. Twelve cases of reported heart problems associated with terbutaline were also found.
The FDA explains that, “… The risk of serious adverse events outweighs any potential benefit to pregnant women receiving prolonged treatment with terbutaline injection (beyond 48-72 hours)… FDA is requiring the addition of a new Boxed Warning and Contraindication to the terbutaline drug labels to warn healthcare professionals about these risks.”
See founding attorney, Lee Coleman, with Hughes and Coleman Injury Lawyers discuss pharmaceutical litigation here.
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