Orange County Terbutaline Injury Attorneys
Terbutaline is a drug which is not approved for use by pregnant women, but which has been used for decades in an “off-label” capacity to stop preterm labor or treat uterine hyperstimulation. Multiple scientific studies and FDA warnings have suggested that use of terbutaline during pregnancy can cause life-threatening or fatal heart problems in women as well as birth injuries or infant death.
If you or a woman or child you love has suffered as a result of terbutaline used during pregnancy, you should know that this is not an FDA-approved use for this potentially dangerous drug and that you could be entitled to significant compensation.
What is Terbutaline?
Terbutaline is a drug used to open narrowed airways in people diagnosed with asthma, emphysema, COPD (chronic obstructive pulmonary disorder), or bronchitis and may be sold under the following brand names:
Terbutaline works by relaxing the muscles that may cause the bronchial tubes to relax, and this same mechanism may help the smooth muscle of the uterus to relax when a woman is in preterm labor or experiencing uterine hyperstimulation. In some cases, terbutaline may also be prescribed over a longer period of time to women carrying multiple babies at once or women with a history of preterm birth to make sure babies are carried as close to term as possible.
Terbutaline may cause Harm or Death to Pregnant Women
Long before the FDA issued a formal warning about use of terbutaline during pregnancy in 2011, a number of scientific studies and adverse event reports drew attention to the serious cardiac risks this drug can pose for pregnant women.
- In a paper published by the journal Obstetrics & Gynecology in 1980, doctors reported on four cases where pregnant women with no history of heart disease were diagnosed with pulmonary edema after taking terbutaline and stated that this drug may cause pregnant women to experience congestive heart failure.
- In 1981, research published in the American Journal of Obstetrics & Gynecology reported, “Severe cardiovascular complications occurred in eight of 160 patients treated with terbutaline for preterm labor.”
- The Journal of the American Medical Association (JAMA) also published a study on the effects of terbutaline on maternal cardiac function in 1981. Here, researchers stated that when women were given terbutaline to stop premature labor, “Heart rate, ejection fraction, and cardiac output increased significantly.”
- The journal Clinics published a study on the life-threatening complications associated with terbutaline therapy for preterm labor in 1986. According to this study, “[Terbutaline] administration for inhibition of preterm labor can result in a number of severe complications for the mother.”
Terbutaline Birth Injuries to Mothers
Terbutaline has been associated with the following serious and potentially fatal health risks when administered to pregnant women to stop or prevent preterm labor:
- Myocardial ischemia
- Cardiac arrhythmias
- Transient hyperglycemia
- Pulmonary edema
- Increased heart rate
According to the FDA, regulators received 16 reports of maternal deaths attributed to terbutaline between 1976 and 2009.
FDA Warns against Terbutaline during Pregnancy
The FDA moved terbutaline from Pregnancy Category B to Pregnancy Category C in 2011 in response to a Citizen Petitionsent to the agency by the Coalition for Positive Outcomes in Pregnancy in 2008. Pregnancy Category C designates drugs for which animal studies have shown fetal risks and for which there is insufficient information on risks to women or female animals.
On February 17, 2011, the FDA stated in a Terbutaline Safety Announcement:
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.
According to the FDA, regulators had received 16 reports of maternal deaths after terbutaline treatment for preterm labor between 1976 and 2009. Even after the FDA issued a “Dear Colleague” letter to warn doctors of terbutaline risks in 1997, there were 12 reports of serious maternal cardiovascular events after terbutaline treatment between January 1998 and July 2009.
Terbutaline Birth Injuries to Babies
A birth injury is any injury suffered by a child before, during, or shortly after delivery. When a woman is given terbutaline to prevent preterm labor, this drug can have severe impacts on her unborn child. Birth defects associated with exposure to terbutaline in the womb include:
- Brain damage
- Speech defects
- Delayed cognition
- Learning disabilities
- Movement disorders
According to a study published in 2013 in the journal Neurotoxicology and Tetralogy, “Prenatal terbutaline exposure is associated with increased incidence of autism.”
Terbutaline may Adversely Impact a Baby’s Heart
While most of the birth injuries and defects associated with terbutaline thus far have been cognitive or neurological, there has been some research linking terbutaline to heart problems in infants.
In 1986, research published by the American Journal of Obstetrics & Gynecology on the effect of terbutaline on fetal heart function in laboratory guinea pigs concluded, “Fetuses exposed to terbutaline demonstrated a higher mean heart rate (p less than 0.01), a higher mean heart weight (p less than 0.05), a higher mean heart weight/body weight ratio (p less than 0.01), and a trend toward higher left ventricular systolic pressure levels (p less than 0.1). These hemodynamic responses in fetuses exposed to terbutaline may result in increased functional demands that may predispose myocardial tissue to damage.”
Research published in the Journal of Perinatal Medicine in 2011 stated that terbutaline may impact fetal heart rate and heart rate accelerations. These researchers concluded, “Terbutaline has a direct effect on the fetal heart apart from the effect of uterine relaxation.”
Terbutaline Lawsuit Consultations
Despite warnings from the FDA as early as 1997, doctors continued to issue terbutaline in extended doses to pregnant women who had entered into preterm labor. Use of terbutaline during pregnancy may be associated with maternal heart problems and maternal death, as well as multiple birth injuries to their babies. If you or a mother or child you love has suffered severe side effects after terbutaline was administered to stop or prevent preterm labor, you could be entitled to compensation. For more information on terbutaline birth injury lawsuits, please contact us to schedule a free and confidential legal consultation with an experienced attorney.