FDA Issues Warning Over Terbutaline in Pregnancy

Washington, DCThe US Food and Drug Administration (FDA) recently issued a warning about the use of terbutaline in pregnancy for the prevention or long-term treatment of preterm labor due to potential heart problems, according to a release from the federal agency.

span itemprop="image" itemscope itemtype="https://schema.org/ImageObject" style="display:block">According to the release, terbutaline has been approved by the FDA to treat the narrowing of the airways associated with conditions such as bronchitis, asthma and emphysema. However, there is reportedly no evidence indicating that it is useful in treating preterm labor, and side effects for the mother can include heart problems.

As a result, the FDA has decided to require a boxed warning and contraindication to the labeling of the drug, according to the release.

In the release, the agency also states that its decision to update the labeling of the drug aligns with previous statements made by the American College of Obstetricians and Gynecologists advising against the use of terbutaline to prevent or treat preterm labor.

According to the National Center for Biotechnology Information, terbutaline typically comes in the form of tablets, which are taken by mouth.