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Terbutaline Sulfate

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.

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Terbutaline

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.

Terbutaline Black Box Warning

heparinwoman 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.

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.

Terbutaline for 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:

"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 Side Effects

drugsideeffects 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.

Serious Terbutaline side effects include:
  • Rapid or irregular heart rhythm, intensification of angina, increased blood pressure (infrequent)
  • Lowered blood calcium or potassium (especially with intravenous use) (possible)
  • Liver toxicity (case reports)
  • Severe lowering of blood pressure (hypotension) (case reports)
  • Increased blood sugar (infrequent)
  • Seizures (rare reports)

Terbutaline Birth Injuries

paxildefectsbirthsideeffects 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."

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."

Terbutaline Timeline

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 Help

If 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 Mar-7-11

TERBUTALINE SULFATE LEGAL ARTICLES AND INTERVIEWS

FDA Issued Multiple Terbutaline Warnings
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
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
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]



READER COMMENTS

Posted by
coleen snider
on
I went into labor at my 16-17th week in 1982. I was given Ritodrine to stop contractions through out the remainder of my pregnancy--the side effects were AWFUL!!!! my son appeared to be a healthy baby boy in 10/1982. However, he cried all the time-screamed like night terrors, He couldn't eat baby food until he was 6-9 mths, banged his head on walls and doors and got very angry when he couldn't do something himself and would not let you show him. During his school years he struggled and just didn't think like other kids. no common sense or book sense. The dr's said he had adhd in his teens, but drug just made him tired. He is almost 33 now and acts like he is stuck at an early age....dr's say he is bi-polar, autistic, disassociative personality disorder, but no meds have helped. he complains of pain often and has no understanding or comprehension of how bad he is. He has generalized anxiety. he needs to be told daily and often or he forgets. He cannot function at a job and ssi has denied him. I wish I knew the effects and I would've never have taken it. My poor baby suffers daily and it's awful. Thank you for listening to my story.

Posted by
lisa collins
on
I was given it more than 5 times and sent home with the pills and really believe that it caused my son to have adhd.

Posted by
California
on
I now have high blood pressure and heart problems cardiovascular issues, my daughter has the same as well as a birth injury that caused her respiratory failure with hypoxia persistent hypertension of the newborn and had to be placed on ECMO machine. Two years later we are still suffering from the side effects of this medication. I have file a suit in San Bernardino court for my injuries and my daughter has until 6 years until we have to file hers. My daughter now has to see specialists and I need some help with this.

Posted by
Washington
on
My son has ADHD, ODD, anxiety and depression. He's emotionally behind (and I have never been the same since June 2004 either! Ten years of suffering!). He's got many issues.

Posted by
Kentucky
on
My son was diagnosed with epilepsy, a mood disorder and learning difficulties.

Posted by
New York
on
I was put on subcutaneous pump of terbutaline at 25 weeks. Son was born with eating problems, generalized anxiety disorder, ADHD, mood disorder. He is now 10 and he has been removed from schools and now I am paying 1500.00 a month for a private school that can handle his disabilities. The list of problems my son has and has had is very long and documented. He was hospitalized at age 8 for trying to hurt himself and the pain and suffering our family goes through on a daily basis is overwhelming.

Posted by
California
on
I am a 23-year-old female. When my mother was 6 months pregnant with me, she went into early labor. She was put on bed rest and Terbutaline for the last trimester of her pregnancy. Fast-forward a few years and 8 months ago I was diagnosed with an Atrial Septal Defect (ASD) which I had closed via femoral artery catheter on Nov. 7 2012. I am still suffering from migraines related to this surgery. My doctors believe the extended use of Terbutaline while I was in the womb caused my heart defect.

Posted by
Colorado
on
I have random odd heart palpitations, and my daughter has suffered from speech, development and physical delays, and has autistic behaviors.

Posted by
Georgia
on
I was on brethine with four of my children. My three boys have asthma. My 8 yr old, has detinogenosis imperfecta. The dentist say that his enamel didn't form on his teeth. My daughter had trisomy 13. During my pregnancy, I was told she was healthy. I saw my Ob and perinatalogist frequently.

Posted by
Oklahoma
on
I was diagnosed in 2001 with hypoglycemia. My oldest son, born in 1998, was born with ASD and VSD. My youngest son, born in 1999, was born with ASD but also suffers greatly with severe Asthma and hyper-sensitivity to foods and environmental stimuli.

Posted by
Washington
on
My mitral valve is "floppy" with a small degree of backward blood flow.

Posted by
Texas
on
My daughter was born with a large defect on her left foot--a very large 2nd toe with a fatty tumor surrounding the top and bottom of her foot. She has had 3 debulking surgeries and 1 amputation of the 2nd toe. She also deals daily with pain and cannot pursue her dance passion due to the pain in her left foot. She has also been diagnosed with ADHD and takes medicine daily for this disability. She struggles in school and always needs tutoring in extra help during the school year.

Posted by
South Carolina
on
I was on Terbutaline by mouth and injections for roughly 2 months to stop preterm labor. My daughter, who never showed any signs of heart problems earlier in my pregnancy, was then born with two faulty heart valves, an ASD, and damaged cardiovascular/pulmonary branch. She has since undergone angioplasty and open heart surgery to correct the defects but still requires continuous monitoring and possible further surgeries throughout the rest of her life.

Posted by
Michigan
on
Birth defects: Brain infection; Learning disabilities; mood disorders: emotionally impaired; bi-polar; is suicidal; needs careful, constant supervision. His dopamine levels recently tested at 10% of normal. He continually acts without weighing consequences and then becomes angry at his inability to control himself. I am unable to work as I am forced to care for my child. In 2000 I was worth over a million dollars and I am now bankrupt. It is highly likely that he will require a life time of supervision.

Posted by
Illinois
on
My son was born with a hole in his heart and both valves faulty. He has a learning disability and has undergone physical, speech and occupational therapy. He has had 2 open heart surgeries and is expected to need another at some point. He also requires special aid in school for physical and learning disabilities.

Posted by
Texas
on
Our son was born with severe stomach problems a minor heart murmur and neurological and nerves system problems.

Posted by
Minnesota
on
I suffered congestive heart failure and permanent disability after C-section causing me to remain out of work for years, financial devastation, loss of bonding opportunity with newborns, inability to breast feed, etc.

Posted by
West Virginia
on
My son was born with a hole in his heart, and he has a chronic kidney condition. I am wondering if this medication may have had an effect on him.

Posted by
Utah
on
My son Jace is 2 yrs old and has autism. He lost language, eye contact, interaction with us in October. We feel that the shot I had during pregnancy may have predisposed him to autism.

Posted by
Illinois
on
1999 son had to have closed heart surgery due to coarctation of the aorta.

Posted by
Tennessee
on
My son was born at 40 weeks; had surgery at 5 days to repair an undetected bowel malrotation. At 20 months my son was diagnosed with Autism.

Posted by
Alabama
on
I had to be given oxygen and my son was born dead, but was brought back a few minutes later. We were both released from the hospital the next day. He got jaundice and then became very sick. He got viral encephalitis meningitis at 19 days old and now has numerous health problems. My son isn't allowed to receive social security disability or social security income and my ex-husband has been out of work for more than two years.

Posted by
Indiana
on
I was given terbutaline while preg. My son now at 3.5yrs is diag. with autism. My daughter 3.5yrs has night terrors and behavioral probs. I believe this drug has caused brain damage in both my children. I need to know if I would have a case. My son is very aggressive and without medication to control the autism he is mostly disfunctional. Little speech ect. My husband and I dont know where to turn. Both my children will need help and medical treatment for the rest of their lives.

Posted by
Connecticut
on
I am pregnant again and see the same dr- I am having the same problem and this dr tells me now some correlation with hyperactivity and learning disabilities. This concerns me because my son is now 1 and a half. He is very hyper at times and doesn't listen. Some normal behavior for little ones, but I would never have taken the risk if I had known. I will not take this drug again during this pregnancy I refuse. I am just very upset because I was given this drug not too long ago and told I had nothing to worry about.

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