FDA Says Terbutaline Use For Preterm Labor is Dangerous
If you are a woman who has ever experienced preterm labor, you have likely received a injection of a drug called terbutaline to slow your contractions. The FDA now warns against this practice, citing risks for serious maternal heart problems and even death.
“Women should be aware that serious and sometimes fatal side effects have been reported after prolonged use of terbutaline in pregnant women,” said Scott Monroe, M.D., director of FDA’s Division of Reproductive and Urologic Products.
Terbutaline, or “terb” as many heat professional refer to it, is the most frequently used medication for the treatment of preterm labor. This off-label use of the medication is legal, however not FDA approved. In fact the only approved use of this medication is for treatment of narrowed airways in respiratory events such as asthma attacks, bronchitis or emphysema.
In their statement, the FDA acknowledges that they have been aware of terbutaline use in pregnant women for preterm labor. After a review of literature and reported events, they are now officially warning against is use and will require a Boxed Warning and Contraindication to be added to prescribing information.
Terbutaline is actually a derivative from the hormone epinephrine. When the human body is under stress this hormone is released to facilitate the “fight or flight” response. It causes the heart rate to speed up and certain muscles to contract so that the body can respond quickly. It also acts on other muscles that are not needed for a fight or flight, such as the uterus, causing them to relax. Therefore, it has been found useful in obstetrical practice to administer terbutaline during preterm labor to relax the uterine muscle and stop contractions.
The FDA has concluded, however, that there is no evidence that this use of the medication improves infant outcomes in the end. Furthermore, the use terbutaline as a preventative measure for preterm labor or prolonged use beyond 48 to 72 hours can actually cause great maternal harm. There have been reported serious adverse events in pregnant women after administration including heart problems and death.
The American College of Obstetricians and Gynecologists have also previously warned against terbutaline use for prevention of preterm labor.
Despite the risks, many practitioners still have continued to give this medication to pregnant women in obstetrical emergencies. Some studies have shown its effectiveness in delaying delivery. How much time the delivery is delayed depends upon how far along the woman was her labor progression before the medication was administered. However, this window of delay may allow for enough time to administer steroid doses, which are given over the course of 48 hours. These steroids quickly mature premature infant lungs and have been shown to significantly improve infant long-term outcomes.
“It is important for patients and health care professionals to consider all the potential risks and known benefits of any drug before deciding on its use.” says Monroe, in acknowledgment there are some situations where a provider may still deem terbutaline administration necessary.
The FDA encourages all patients and health care professional to report any side effects that have occurred result of terbutaline use to their MedWatch program at www.fda.gov/MedWatch