U.S. drug regulators are cautioning doctors about the use of the asthma medicine terbutaline for treatment of preterm labor due to the hazard of fatal heart problems that have killed at least 12 women since 1998.
The FDA issued a terbutaline medicine safety communication on Thursday telling that the asthma medicine should not be used on pregnant women for the prevention or extended treatment of preterm labor. The organization is also requiring a black box warning to be found on the drug and is adding a contraindication for preterm labor use.
Terbutaline is approved by the FDA to treat airway constraint caused by asthma, bronchitis and emphysema. However, the medicine is also popular among obstetricians and gynecologists to stop preterm labor or to treat preterm labor that lasts for more than 48 hours. This off-label use has never been accepted by the FDA, but doctors are allowed to use medicines for any treatment they see as beneficial to their patient.
The FDA has been worried about the application of terbutaline by pregnant women since at least 1997, when it issued a “Dear Colleague” letter about concerns regarding heart problems that appeared to be linked to subcutaneous applications of the drug. Since that time, the organization has studied medical reports and other writing on the medicine and has found that it is unsafe and ineffective in treating or preventing preterm labor. It has also been linked to the deaths of 12 pregnant women since 1998 and at least 16 since 1976.
The deaths of the pregnant women were linked to a number of terbutaline heart side effects, including cardiac arrhythmias, heart attacks, pulmonary edema, hypertension and tachycardia. The women were given oral terbutaline, terbutaline injections, or both.
The FDA recommends that patients know that there may be serious situations where a healthcare professional determines that short time of use of the medicine in a hospital setting may be necessary, but pregnant women need to be aware of terbutaline side effects, including maternal heart problems and death, that have been associated with use of the medicine to treat preterm labor.