Navigation Links
FDA Warns Against Certain Uses of Asthma Drug Terbutaline for Preterm Labor
Date:2/17/2011

SILVER SPRING, Md., Feb. 17, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration is warning that terbutaline administered by injection or through an infusion pump should not be used in pregnant women for prevention or prolonged (beyond 48-72 hours) treatment of preterm labor due to the potential for serious maternal heart problems and death. In addition, oral terbutaline tablets should not be used for prevention or treatment of preterm labor. The FDA is requiring the addition of a Boxed Warning and Contraindication to the drug prescribing information (labeling) to warn against these uses.

(Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO)

Terbutaline is FDA-approved to prevent and treat narrowing of the airways (bronchospasm) associated with asthma, bronchitis, and emphysema. The drug is used off-label for obstetric purposes, including treating preterm labor and treating uterine hyperstimulation. Terbutaline has also been used in an attempt to prevent recurrent preterm labor. There is no evidence, however, that use of terbutaline to prevent preterm labor improves infant outcomes. Serious adverse events, including maternal deaths, have been reported with such use in pregnant patients.

"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. "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."

The FDA is aware that administration of terbutaline by injection to pregnant women is used in hospital settings in certain urgent situations. The FDA warning relates to safety concerns about the prolonged use of terbutaline injection beyond 48-72 hours, and against any use of oral terbutaline in pregnant women for prevention or treatment of preterm labor.

The decision to require a Boxed Warning and Contraindication is based on the FDA's review of post-market safety reports of heart problems and even death associated with terbutaline use for obstetric indications, as well as data from medical literature documenting the lack of safety and effectiveness of terbutaline for preventing preterm labor, and animal data suggesting potential risks. Based on this information, the FDA concluded that the risk of serious adverse events outweighs any potential benefit to pregnant patients for either prolonged use of terbutaline injection beyond 48-72 hours or use of oral terbutaline for prevention or treatment of preterm labor.

These changes to the drug labeling are consistent with statements from the American College of Obstetricians and Gynecologists discouraging use of terbutaline for preventing preterm labor.

There are multiple generic versions of terbutaline oral tablets and injectable formulations available. The brand name products were previously discontinued by the companies that made them.  

The FDA encourages patients to talk to their health care professional if they have concerns about any treatment they are receiving. Patients and health care professionals should report any side effects from the use of terbutaline to the FDA's MedWatch adverse event reporting program at www.fda.gov/MedWatch.

For more information:

Drug Safety Communication: Use of Terbutaline for Preterm Labor

http://www.fda.gov/Drugs/DrugSafety/ucm243539.htm

FDA Citizen Petition Response: Terbutaline Sulfate, Docket No. FDA-2008-P-0358

http://www.fda.gov/downloads/Drugs/DrugSafety/UCM243797.pdf

Media Inquiries: Sandy Walsh, 301-796-4669, sandy.walsh@fda.hhs.gov

Consumer Inquiries: 888-INFO-FDA


'/>"/>
SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Agriculture Department Warns Consumers of Tainted Raw Milk Sold by Chester County Dairy
2. Agriculture Department Warns Consumers of Tainted Raw Milk Sold by Lebanon County Dairy
3. New Federal Stem Cell Rules Would Hinder Existing Research, Consumer Group Warns
4. Orkin Warns of Four Pests to Avoid this Fourth of July
5. FDA Warns Consumers about Counterfeit Alli
6. Toxic Chemical bisphenol A Still Not Banned By FDA; Schumer, Gillibrand Call for Ban; Govt Official Warns Public
7. Physicians Foundation Warns of Potential Impact From New Medicare Cuts Effective Today
8. H.E.A.T. Warns Drivers, Auto Dealers of Continuing Trend in Unconventional Auto Crimes
9. FDA Warns Users About Faulty Components in 14 External Defibrillator Models
10. FDA Warns About Fraudulent Tamiflu
11. FDA Warns Consumers to Avoid TimeOut Capsules
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/11/2017)... , Oct. 11, 2017  Hill-Rom Holdings, Inc. ("Hill-Rom") ... Surgical facility in Las Piedras, Puerto Rico ... and blades. ... the facility sustained minor structural damage, temporary loss of ... Repairs have been completed, manufacturing operations have resumed, and ...
(Date:10/4/2017)...  South Korean-based healthcare product Development Company I.M. Lab ... Kickstarter. The device will educate the user about ,proper, ... efficiency compared to the dated and pricey CPR training ... of the compression for a more informed CPR training. ... raise $5,000. cprCUBE ...
(Date:10/2/2017)... Fla. , Oct. 2, 2017  AllianceRx Walgreens ... company formed by Walgreens and pharmacy benefit manager Prime ... its new brand, which included the unveiling of new ... , as well as at a few other ... the new brand to patients, some of whom will ...
Breaking Medicine Technology:
(Date:10/12/2017)... ... 2017 , ... HMP , a leader in healthcare events and education, today ... Digital Award for ‘Best B-to-B Healthcare Website.’ Winners were announced during the Eddie & ... award competition recognizes editorial and design excellence across a range of sectors. This year’s ...
(Date:10/12/2017)... ... ... On Saturday, October 21, the Health & Wellness Center at Florida Hospital ... for the American Heart Association Heart Walk. Teams of up to 10 people can ... their treadmills moving for 5 hours. Treadmills will start at 7:00 p.m. on Saturday, ...
(Date:10/12/2017)... ... October 12, 2017 , ... ... nation's first interactive health literacy software tool, and the Cancer Patient Education Network ... cancer patient education, today announce a new strategic alliance. , As CPEN’s ...
(Date:10/12/2017)... Miramar, FL (PRWEB) , ... October 12, 2017 ... ... is presenting the latest in wound care advancements to physician colleagues, skilled nursing ... lecture is titled, "Navigating the Treacherous Waters of Wound Care." , "At many ...
(Date:10/12/2017)... CHICAGO (PRWEB) , ... October ... ... innovator in life sciences content management, presents its enhanced Pepper Flow promotional ... Oct. 16 -18, 2017. Pepper Flow’s increased insight-driven capabilities help marketers streamline ...
Breaking Medicine News(10 mins):