The US Food and Drug Administration (FDA) has announced that it recommends that clinicians not use the injectable drug terbutaline for the prevention of preterm labor or treatment beyond 48 to 72 hours. The FDA says that use of the drug could risk maternal heart problems and even death.
According to the FDA, the oral version of terbutaline should be avoided in addition to the injectable form for treatment or prevention of acute or prolonged preterm labor as it is equally risky and has yet to be proven as an effective drug.
Terbutaline may be clinically neccessary in some emergency situations, but the FDA says that injections of the drug should only be administered by medical professionals in a hospital setting.
The drug should not be injected outside of hospital settings and use of the drug for treatment should never reach beyond 48 to 72 hours. Labels for both the injectable and oral variations of the drug will be ammended to reflect the FDA's warning and an additional message further warning of the risks for use among pregnant women.
The drug terbutaline, which is an FDA-approved bronchodilator, is used in the prevention and treatment of bronchospasms that are associated with respiratory diseases such as bronchitis and asthma. However, some medical professionals use the drug for the treatment of preterm labor and other obstertrical uses.
Terbutaline has also frequently been used to prevent recurring preterm labor in women.
An outside agency's review of use of the drug for obstetrical purposes found reports of maternal death as well as severe cardiovascular effects, prompting warnings from the FDA.
The drug was first marketed in 1976. From that year until 2009, 16 maternal deaths were recorded and 12 different pregnant women suffered severe caridovascular events. In their warning, the FDA says that the risks greatly outnumber any possible benefit from use of the drug.
Contact the Law Offices of Dr. Bruce G. Fagel at (800) 541-9376.
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