Home Page Hot Legal Issues Terbutaline (birth defects, heart damage)
Terbutaline Sulfate is used to treat asthma, bronchitis, and emphysema. Terbutaline during pregnancy is associated with serious Terbutaline side effects, including serious maternal heart problems and death. Doctors give Terbutaline for preterm labor in certain urgent situations, but the risks of the Terbutaline drug are now believed to outweigh the benefits.
Terbutaline Sulfate (also known as brand names Brethaire, Brethine, Brican, Bricanyl, Bricar, Bricaril, Bricyn, Terbutalin, Terbutalina, Terbutalino, Terbutalinum) is an FDA approved asthma drug in the drug class of beta-adrenergics. It is used to help prevent asthma attacks and treat bronchitis and emphysema by relaxing bronchial tubes and easing asthma symptoms.
It also is thought to relax the muscles of the uterus, which led manufacturers to promote Terbutaline for preterm labor. Terbutaline is not approved by the FDA for this purpose, therefore it is used "off-label" by physicians to control preterm labor. (Generally, preterm labor's signs are contractions with cervical changes—i.e., effacement and dilation--before full-term gestation.)
The unapproved ("off label") use of Terbutaline has recently been linked to an increase in birth injuries and maternal side effects. Terbutaline side effects can be very dangerous, particularly to babies. Terbutaline adverse events have consequently led to a number of Terbutaline lawsuits.
On February 17, 2011 the FDA issued a black box 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. The FDA's decision was based on its 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.
Terbutaline Black Box Warning
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.
According to Dr. Fink on the website Pregnancy Today, a medication known as ritodrine was approved by the FDA in 1980 as a labor-inhibiting agent but it is no longer on the market. Since terbutaline is so similar, it is frequently used in preterm labor to relax the uterine muscles and stop the contractions. The website further states that:
Terbutaline for Preterm Labor
"Many pregnant women have crampy preterm uterine contractions that cause them to present to labor and delivery units for evaluation and treatment. Terbutaline is often given in the form of a subcutaneous injection to stop these annoying uterine contractions."
Terbutaline's side effects are more severe at higher dosages. According to The Essential Guide to Prescription Drugs, 1998 and 1999 Physicians' Desk Reference, the maximum dose of oral terbutaline for asthmatics is 15 mg per 24-hour period. Women experiencing preterm labor will often take double the maximum dose for asthmatics, (30 mg per 24-hour period) or even higher dosage.
Terbutaline Side Effects
Serious Terbutaline side effects include:
There have been reports of neurological deficits in the newborn infants when Terbutaline sulphate was used "off label" to prevent early labor in pregnant women.and the FDA has issued warnings that such use is "... not approved and may cause harm to the mother and/or the fetus."
Terbutaline Birth Injuries
According to the National Library of Medicine, Terbutaline crosses the placenta where it can stimulate receptors in fetal tissues, which in turn use betaAR input for trophic control of cell replication and differentiation. Significant statistical association between terbutaline and cardiac anomalies in epidemiological studies suggest that terbutaline may sensitize the developing heart to other insults that affect development.
Terbutaline Animal Study
"Neonatal rats are at a stage of neurodevelopment corresponding to human fetal development. This study on postnatal effects of terbutaline indicated structural abnormalities in the cerebellum, hippocampus, and somatosensory cortex. In the cerebellum, terbutaline treatment reduced the number of Purkinje cells and elicited thinning of the granular and molecular layers."
1994: Terbutaline first entered the market after receiving FDA approval to treat asthma and other bronchial maladies. The FDA did not approve terbutaline for prevention of preterm labor, and it is considered an off-label use of the drug.
1997: the FDA issued its first warning about the use of Terbutaline Sulfate for the treatment and prevention of preterm labor. Terbutaline sulfate, in various dosage forms, has been approved by FDA for the treatment of asthma but it has be given to pregnant women subcutaneously, to stop early labor. The use of Terbutaline sulfate to treat preterm labor is an unapproved or "off-label" use. Premature labor occurs in approximately 20 percent of all pregnancies in the United States. In 1997, the FDA issued a cautionary letter, warning doctors against prescribing terbutaline for prolonged treatment of preterm labor. Read the full text of the FDA letter.
1998: The Journal of the American Medical Association (JAMA) published a report by Stuart Nightingale, MD, who alerted the FDA and physicians to concerns about subcutaneous administration of terbutaline sulfate via infusion pump for off-label use as treatment and prevention of preterm labor (tocolytic therapy). Women appeared to have complications that included chest pain, tachycardia, dyspnea, and pulmonary edema. At least 1 maternal death occurred during outpatient use of a continuous infusion of terbutaline sulfate by subcutaneous pump.
2004: A report (PubMed: Department of Pharmacology and Cancer Biology, Duke University Medical Center) determined that Terbutaline is a developmental neurotoxicant. "These effects point to a causal relationship between fetal terbutaline exposure and the higher incidence of cognitive and neuropsychiatric disorders reported for the offspring of women receiving terbutaline therapy for preterm labor."
February 17, 2011: The FDA issued a warning that terbutaline administered by injection, by oral terbutaline tablets, 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. The FDA is requiring the addition of a Boxed Warning and Contraindication to the drug prescribing information (labeling) to warn against these uses.
Terbutaline Sulfate Side Effects HelpIf you or a family member have taken Terbutaline Sulfate and have experienced any side effects, you may be entitled to compensation. If you feel you qualify for damages or remedies that might be awarded in this possible lawsuit, please click the link below to submit your complaint.
Last updated on May-31-12
TERBUTALINE SULFATE LEGAL ARTICLES AND INTERVIEWS
FDA Issued Multiple Terbutaline Warnings
Washington, DC: It has been almost a year since the US Food and Drug Administration (FDA) issued a warning about Terbutaline side effects. It has been more than 10 years since the FDA issued an initial warning about the use of Terbutaline during pregnancy, following reports of death in women who used Terbutaline sulfate while pregnant. Since that time, however, terbutaline was still used to treat preterm labor, putting women's lives at risk [READ MORE]
Terbutaline Mothers Lament Potential Harm to Their Kids
Washington, DC:: No one would argue that a healthy debate is a good thing—such as the debate that continues to rage over Terbutaline Sulfate and whether or not the drug is harmful to the fetus when prescribed to the mother to ward against, or stop premature labor. What's worse? The possibility of premature labor and the potential for negative outcomes? Or use of a drug that has been shown to stop premature contractions, but could pose maternal or natal harm [READ MORE]
Health Organizations Issue Warnings about Use of Terbutaline during Pregnancy
Baltimore, MD: The US Food and Drug Administration (FDA) is not the only health organization to issue a warning about terbutaline side effects. In fact, the American College of Obstetricians and Gynecologists has also recommended against long-term use of terbutaline during pregnancy. Specifically, the organization warned about prolonged use of terbutaline for the treatment or prevention of preterm labor [READ MORE]
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