The Federal Drug Administration (FDA) recently issued a new warning about a medication that has been used for years and it has sent shock waves throughout my specialty. Terbutaline is an FDA approved medication that is used for asthmatic patients or patients who have significant narrowing of the airways. However for years it has been used as an “off-label” medication to treat preterm labor but now that’s about to change. An off-label drug means it hasn’t been approved for that specific use by the FDA.
According to the FDA, the injectable form of Terbutaline should only be used for a maximum of 24 to 72 hours because the drugs association with heart problems and death. The FDA goes on to say that the oral version (pills) should not be prescribed to treat preterm labor because it’s ineffective and can cause similar problems. As an obstetrician, I feel utterly betrayed. The medication clearly had side effects that included shortness of breath and a racing heart. As resident physicians we were taught that the benefit outweighed the risks of having a premature baby and the patients should try to adjust to the medication.
We now learn that there have been 16 maternal deaths from 1976 until 2009 that have been associated from the use of Terbutaline. In 1997 the FDA issued a warning about its prolonged use but the prescribing patterns by physicians did not appear to change. There have also been 12 reported cases of mothers with serious heart conditions that were also associated with the use of Terbutaline; hence, the need for a repeat warning.
There are maternal fetal medicine specialists that think Terbutaline should not be abandoned completely and cite clinical conditions such as an over stimulated uterus, the need for a relaxed uterus and transporting a patient from one institution to another while in preterm labor as a reason for the short-term use of Terbutaline.
In view of the FDA warnings, it is important for all pregnant women to be aware of the medications they are receiving, especially if they develop preterm contractions. Terbutaline should only be given in a hospital for a maximum of three days and never taken at home.
Remember, a healthy pregnancy doesn’t just happen. It takes a smart mother who knows what to do.