FDA Warns Against Use of Drug Popular in Stopping Premature Labor
The FDA now warns against use of the drug terbutaline to prevent premature birth
After years of promoting the drug for use in maternity care, he U.S. Food and Drug Administration (FDA) is released a warning this week terbutaline injections should not be used to stop pre-term labor in pregnant women because the drug may "serious maternal heart problems and death."
Terbutaline is regularly used in most Seattle hospitals to stop pre-term labor and thus prevent a baby being born prematurely. It is also used to prevent contractions when providers (usually obstetricians) are attempting a version, a procedure where the provider manipulates the belly externally to turn a breech baby head down. Breech presentation almost always leads to Cesarean section in Seattle hospitals as it does across the U.S. The FDA warns that the drug should not be used in either a hospital setting or in a home setting.
As part of it's announcement Feb. 17, the FDA said it will now require drug manufacturers to include a Boxed Warning and Contraindication section to both the terbutaline injection and oral medication labels to warn doctors against using it on pregnant women.
Terbutaline was first approved to prevent and treat the narrowing of airways that is associated with asthma, bronchitis, and emphysema. The use of the drug in obstetrics has always been off-label, that is an unapproved use. Terbutaline has also been used off-label over longer periods of time in an attempt to prevent recurrent preterm labor.
The decision to require the addition of a Boxed Warning and Contraindication is based the FDA's review of postmarketing safety reports of terbutaline used for obstetrical indications. According to the agency's review report:
"The FDA has concluded that the risk of serious adverse events outweighs any potential benefit to pregnant women receiving prolonged treatment with terbutaline injection (beyond 48-72 hours), or acute or prolonged treatment with oral terbutaline."
To learn more, go online to FDA Terbutaline warning.
Additional Information for Patients
Be aware that serious side effects, including maternal heart problems and death, have been reported after prolonged use of terbutaline to manage preterm labor.
There are serious situations where a healthcare professional may decide that the short-term use of injectable terbutaline in the hospital setting may benefit a pregnant woman.
Oral terbutaline should not be used either to treat preterm labor or prevent recurrent preterm labor.
If you are taking terbutaline for another medical condition (e.g., asthma), talk to your healthcare professional if you are pregnant or become pregnant to determine whether terbutaline is still right for you.
FDA encourages patients to talk to their healthcare professional if they have concerns about any treatment they are receiving.
Report any side effects from the use of oral or injectable terbutaline to the FDA MedWatch program, using the information in the "Contact Us" box at www.fda.gov/MedWatch.
Cheryl Murfin is a owner of NestingInstincts.org, a doula service, and publisher’s associate for Seattle’s Child.