LAWSUITS NEWS & LEGAL INFORMATION
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.
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.
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:
"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.
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."
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.
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Terbutaline
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
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
"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
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
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
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
TERBUTALINE SULFATE LEGAL ARTICLES AND INTERVIEWS
FDA Issued Multiple Terbutaline Warnings
Terbutaline Mothers Lament Potential Harm to Their Kids
Health Organizations Issue Warnings about Use of Terbutaline during Pregnancy
February 4, 2012
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
January 7, 2012
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
December 7, 2011
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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READER COMMENTS
Christina
on
From 27 weeks to 36 weeks for pre term
Labor in 1998. Daughter was born w low blood
Sugars. Has learning disabilities and struggled thru school
Academically
And socially her whole childhood. Also diagnosed an anxiety panic depression and OCD.
Colleen Brower
on
Mitzi Stone
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Morgan Albano
on
California
on
I suffered with my heart during my hospitalization and all the other side effects of the drug. I was told that the drug would not have any effect on the babies and that it only would have an effect on me.
1995 delivered twin girls by c-section
Baby A - very confident, highly intelligent and an over achiever. birth weight 3 lbs. she does suffer from gastrointestinal issues, but she has controlled it by becoming vegan and through exercise.
Baby B - learning disorders, anxiety and the need for speed. weight 5 lbs at birth. She is now 23 and addicted to speed. She is living in a sober living environment and she is determined to beat her mind that says take speed. She is learning to do the opposite of what her mind is telling her. She is very determined by not appreciated by her strength in helping herself. Her father and sister blame her for being an addict. She struggled in school her entire life.
My question is - will terbutaline have further damage to my kids.
Xiomara Ingram
on
Thanks
Kearney Waites
on
Kearney Waites - Director
Mississippi Industries for the Developmentally Disabled
MIDD - West
100 Smokey Lane
Vicksburg, MS 39180
Rebecca
on
Kelly Sidebottom
on
This was in 1990 and the FDA had already put out a cease and desist letter to physicians in 1991. I saw the letter. There was also a study done in 1986 that I saw that said there was an increased risk of hemiparesis in children with terbutaline use for pre term labor.
Why are there no long term studies. I am a few numbers away from a need for a heart transplant and my son is 26 and struggling with the many issues still to this day from this drug. All known issues and this drug has been used for a long time before 1994. The reason it hasn't been a class action because the drug company put not for pre term use on the label so the drug company is not at fault yet my son and I still struggle with the damage this drug caused and no one will help us.
I have stage 3 heart failure due to diastolic dysfunction caused by long term arrhythmias. I had no arrhythmias before they used this toxin on me in extreme high doses for ten weeks when I could have stayed in the hospital on mag with much less dosing. I was not told of the risks or that it was an off label use. I was told that it had the same issues as magnesium and that the babies were sometimes irritable and had low blood sugar but it would resolve quickly after birth and better than being born at 25 weeks but I should not have been sent home on the terbutaline pump for 10 weeks to save the insurance money.
I will survive as long as I survive because I can't afford a transplant and I am 57 and if I go I go, but my son is 26 and did get a degree but is really struggling with Epilepsy and Cerebral Palsy and the drugs he needs and the fact he lost his insurance and no longer coping well and is losing hope. He has a hard time focusing, switching subjects, memory issues and just general not real connected at times and this is holding him back for a career and I am losing hope for him that this drug didn't hurt him. It did hurt his chances for life and he should be able to get help and be disabled if necessary if he can't ever function consistently enough to have long term employment due to his health issues that I lay at the doorstep of those who decided terbutaline was a good choice.
We need long term studies on these children. We were called several times over the years by the FDA. I know someone was doing research on the children up until 2000.
Kristie Jones
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Michelle
on
He has ADHD and I developed a food allergy. I wonder if these are related to this drug.
Yvette
on
My daughter was has always been short in stature and has always had difficulty with focus and is very moody. She also seems to lack energy and had a rare infection of her brain and spine which doctors could not explain. She also has an elevated ANA level and has to be monitored ongoing.
KIERKIER
on
cheryl
on
He has tons of health issues, Autism, tacky/brady syndrome of the heart. He is on pace maker #3. Blood clots and blockages through out his body. Casanova medusa veins. 25 inches long that we watch so it does not brake. Astma , pain in the right lung? Mystery yet to figure out. Small valve rotation of the stomach. Which means guts are flipped. Appendix was laying on top of the large intestine flopping back and forth. still vomits daily for months at a time. weight goes from 115 to 140. skinny as a rail zero % body fat. He was home schooled as of the 6th grade. the school said he was to stupid to be there and was suspended for 3 days for eating a corner of a math paper. Many more health issues. Never ever take anything t stop ur labor, My sister lost her 6 pound baby Boy from this same drug. His twin survived but also has health issues and has a hard time with out her twin at her side. My son is still a mess and its been 28 years for him and us.. Good luck to you all.
mrs. rosa
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Katherine Gonzalez
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Chelly
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Amanda Schaefer
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Kathy Pardue
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Carol Heaton
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Therese
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trina hamil
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Wanda
on
I searched for this because I had a strange feeling about the terbutaline, even after 22 years. My sons issues has been a huge burden on my family. This website says the drug was introduced in 1994 but that has to be inaccurate since I received it in 1992.
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