I was put on terbutaline in the beginning of my 7th month of pregnancy to stop and control premature labor. I was told to take a pill 4 times a day to ensure i didn't go into labor. My son was full term and is fairly grown. What I really need to know is what are the possible effects to my son after my being on this medication for close to 3 months?
Terbutaline sulfate has not been approved and should not be used for tocolysis (premature uterine contractions). Serious adverse reactions may occur after administration of terbutaline sulfate to women in labor. In the mother, these include increased heart rate, transient hyperglycemia, hypokalemia, cardiac arrhythmias, pulmonary edema, and myocardial ischemia. Increased fetal heart rate and neonatal hypoglycemia may occur as a result of maternal administration.
Here is the announcement from the FDA:
The U.S. Food and Drug Administration (FDA) is warning the public that injectable terbutaline should not be used in pregnant women for prevention or prolonged treatment (beyond 48-72 hours) of preterm labor in either the hospital or outpatient setting because of the potential for serious maternal heart problems and death. The agency is requiring the addition of a Boxed Warning and Contraindication to the terbutaline injection label to warn against this use. In addition, oral terbutaline should not be used for prevention or any treatment of preterm labor because it has not been shown to be effective and has similar safety concerns. The agency is requiring the addition of a Boxed Warning and Contraindication to the terbutaline tablet label to warn against this use.
Terbutaline is approved to prevent and treat bronchospasm (narrowing of airways) associated with asthma, bronchitis, and emphysema. The drug is sometimes used off-label (an unapproved use) for acute obstetric uses, including treating preterm labor and treating uterine hyperstimulation. Terbutaline has also been used off-label over longer periods of time in an attempt to prevent recurrent preterm labor.
Although it may be clinically deemed appropriate based on the healthcare professional's judgment to administer terbutaline by injection in urgent and individual obstetrical situations in a hospital setting, the prolonged use of this drug to prevent recurrent preterm labor can result in maternal heart problems and death. Terbutaline should not be used in the outpatient or home setting.
The decision to require the addition of a Boxed Warning and Contraindication is based on new safety information received and reviewed by the FDA. Specifically, FDA has reviewed postmarketing safety reports of terbutaline used for obstetrical indications (see Data Summary below), as well as data from the medical literature.1-6 These label changes are consistent with statements from the American College of Obstetricians and Gynecologists (ACOG).6
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 the bottom of the page.
Additional Information for Healthcare Professionals
Be aware that death and serious adverse reactions, including increased heart rate, transient hyperglycemia, hypokalemia, cardiac arrhythmias, pulmonary edema, and myocardial ischemia have been reported after prolonged administration of oral or injectable terbutaline to pregnant women.
Treatment with terbutaline administered by injection or by continuous infusion pump should not be used beyond 48 to 72 hours. In particular, injectable terbutaline should not be used in the outpatient or home setting.
There are certain obstetrical conditions where the healthcare professional may decide that the benefit of terbutaline injection for an individual patient in a hospital setting clearly outweighs the risk.
Oral terbutaline is contraindicated for the treatment or prevention of preterm labor.
Report adverse events involving terbutaline to the FDA MedWatch program using the information in the "Contact Us" box at the bottom of this page.
In November 1997, FDA issued a Dear Colleague letter to notify healthcare professionals about concerns regarding the safety of long-term subcutaneous administration of terbutaline. The Precautions section of the labeling was revised to warn about serious adverse reactions, including cardiovascular adverse events that may occur after administration of terbutaline to women in labor.
Publications in the medical literature have reported a lack of safety and efficacy of terbutaline for the treatment of recurrent preterm labor.2-5 Despite labeling changes, FDA's communication to the public, and professional association recommendations, prolonged use of terbutaline continues, with serious and sometimes fatal consequences.
FDA reviewed postmarketing reports of maternal death and serious cardiovascular adverse events submitted to the Adverse Event Reporting System (AERS) associated with obstetric use of terbutaline.
A search of AERS identified 16 maternal deaths that were reported since initial marketing of the drug in 1976 until 2009. Three of the 16 cases reported outpatient use of terbutaline administered by a subcutaneous pump, while nine cases reported use of oral terbutaline alone or in addition to subcutaneous or intravenous terbutaline. Of these nine cases, two reported use of oral terbutaline on an outpatient basis and seven cases involved inpatient use of oral terbutaline. The routes of administration in the remaining four cases were subcutaneous, intravenous, or unknown.
FDA identified 12 maternal cases of serious cardiovascular events associated with use of terbutaline that were reported to AERS between January 1, 1998 (after FDA issued the Dear Colleague letter) and July 2009. These events included cardiac arrhythmias, myocardial infarction, pulmonary edema, hypertension, and tachycardia. Three of the 12 cases reported use of the terbutaline administered by subcutaneous pump. Five cases involved use of oral terbutaline alone or in addition to subcutaneous terbutaline. Of these five cases, three cases involved use of oral terbutaline on an outpatient basis and two cases involved inpatient use of oral terbutaline.
In summary, based on this information, 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. FDA is requiring the addition of a new Boxed Warning and Contraindication to the terbutaline drug labels to warn healthcare professionals about these risks.
Here are the warnings in the drug literature:
Pregnancy Category B
A reproduction study in Sprague-Dawley rats revealed terbutaline sulfate was not teratogenic when administered at oral doses of 50 mg/kg (approximately 25 times the maximum recommended daily oral dose for adults on a mg/m2 basis). A reproduction study in New Zealand white rabbits revealed terbutaline sulfate was not teratogenic when administered at oral doses up to 50 mg/kg (approximately 55 times the maximum recommended daily oral dose for adults on a mg/m2 basis).
There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human responses, this drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. (see PRECAUTIONS, Tocolysis).
Use in Labor and Delivery
Because of the potential for beta-agonist interference with uterine contractility, use of terbutaline sulfate tablets, USP for relief of bronchospasm during labor should be restricted to those patients in whom the benefits clearly outweigh the risk.
Terbutaline crosses the placenta. After single dose IV administration of terbutaline to 22 women in late pregnancy who were delivered by elective Cesarean section due to clinical reasons, umbilical blood levels of terbutaline were found to range from 11% to 48% of the maternal blood levels.
It is not known whether this drug is excreted in human milk. Therefore, terbutaline sulfate tablets, USP should be used during nursing only if the potential benefit justifies the possible risk to the newborn.
- Terbutaline Information for Consumers
- Terbutaline Information for Healthcare Professionals (includes dosage details)
- Side Effects of Terbutaline (detailed)
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