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FDA Issued Multiple Terbutaline Warnings

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Washington, DCIt 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.

On February 17, 2011, the FDA issued a warning that injectable terbutaline should not be used in pregnant women for more than 48 to 72 hours to prevent preterm labor. The agency warned at the time that pregnant women faced a risk of serious heart problems, possibly resulting in death, and noted that a boxed warning would be added to the injection label.

"In addition," the FDA noted, "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 FDA further noted that in urgent situations in the hospital, doctors could use their judgment in administering terbutaline, the drug should not be used in an outpatient or home setting.

The FDA issued the warning after reviewing post-marketing reports of maternal death and cardiovascular adverse events associated with the use of terbutaline in pregnant women. The adverse events reports included information of 16 cases of maternal death from 1976 through 2009, including nine cases of death associated with oral terbutaline.

In November 1997, the FDA issued a Dear Colleague letter, warning about the long-term use of subcutaneous administration of terbutaline. Since that time, however, the FDA received an additional 12 reports of serious cardiovascular events associated with the use of terbutaline during pregnancy.

Terbutaline is approved to treat symptoms of asthma and bronchitis, but is not approved to treat preterm labor. The drug is marketed as Brethine and Bricanyl, according to the Los Angeles Times (02/18/11).

In addition to the potential for life-threatening side effects, terbutaline has been shown in some studies to be ineffective in preventing preterm labor. Furthermore, the American College of Obstetricians and Gynecologists (2003; online at, found, "there are no clear 'first-line' tocolytic drugs to manage preterm labor" and "neither maintenance treatment with tocolytic drugs nor repeated acute tocolysis improve perinatal outcomes; neither should be undertaken as a general practice." In other words, babies who are exposed to tocolytic drugs—including terbutaline—to prevent preterm labor do not receive benefits from the use of terbutaline. Tocolytic drugs include terbutaline.

Despite the FDA warning physicians in the past that the long-term use of terbutaline for preterm labor was both not effective and potentially dangerous, the agency noted that such use of terbutaline still occurs, "with serious and sometimes fatal consequences."


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Posted by

Im now 52yro and felt I should look up this medication. I guess out of curiosity and free time to spare. I was blown away by all the stories I read about damages to the mother and children. My children are all grown now, but it doesn't change the fact all of us mom's have experienced exactly the same medical issues. I got pregnant in 1989 with my first daughter I started experiencing preterm labor In my 6th month. My ob/gyn prescribed terbutaline . Not knowing at that time my extreme swelling of my hands, face ,legs, and feet. It was so bad I couldn't even were slide on slippers or socks, my skin felt like it was tearing. Doctor said I had toxemia and would go down if stayed off my feet and elevated them.may 17, 1990, my daughter was born and swelling left. I never thought the problems my newborn and I were having was related to the medication. She was severely colic screamed all night, nothing ever soothed her, pacing up and down the bumpy sidewalk for hours at night, doctor said to place her on her belly and it will help her didn't I strived to comfort her and it eventually disappeared over a few months. She started having chronic ear infections from the start.she started walking around 1yr , she always seemed a little disconnected , play alone in her room and didn't really interact if she had other kids around. At times she was aggressive, hitting or biting when she did interact. Have tantrums of screaming and throwing herself on the floor, I let go til she was over the moment just thinking it's her age. I got pregnant again in 1991, again preterm labor this time at 7months and again prescribed terbutaline.this time I had another whole experience. I formed a heart murmur with my second pregnancy, and we couldn't find the babies. Concern set in after 2 exams and the doctor had trouble as if there wasn't pregnant. It started a series of ultrasounds. I started getting bad dizzy spells and cold sweats my second daughter was already preparing me for round two. I involved my first daughter in hopes she would adjust to her new sibling when she arrived. May 24,1992 our new addition joined us. Her body temperature dropped as soon as I delivered and had to be placed in warmer unit to raise her to a stable temperature. She was slightly jaundice and it was then I started wondering, 2 babies,both preterm labor and treatment with the same medication. Until 2weeks later when she stopped breathing on me medics arrived quickly and she responded well and normal. She received a good bill of health. she started having febrile seizures, first time she was a month old, 30sec full body tremor on July 3,92. Hospital bound and testing and 2 spinal taps, her temperature 99.6 not fever. She was put on phenobarbital for one year. There was no further problems. My first daughter is showing signs of speech problems,she say free instead three, cool instead of school. I had a program come in called Leap, and they did an assessment. She showed signs of speech problems, poor focus, easily agitated and she demonstrated a writing pattern from right to left. Her assessment at age 3 was she was 6months behind kids her age. The caseworker said she may benefit going to a headstart program at age 4 and it may help get her up to the level of her peers. To make her story short ,she was diagnosed by 1st grade with dyslexia, learning disabled, illiterate, letter and sound recognition was of a kindergarten student. Her IEP scores through out her schooling were 1 1/2 yrs behind her age group. Push in support, testing in a different room, 5:1 student/teacher. Special needs student . she was a behavioral problem and was being considered for a fully disabled class because she was so erratic and displayed anger.she completed all her schooling under special provisions. She was suspended for reckless behavior on several occasions.she rarely showed emotion on or about anything. Her sister had her battles to come, at 2 yrs on July 4th she her second seizure and her temperature this time 100.1,another year and repeat medication. I asked what was causing the seizures and they told me the seizures she was having were caused by the slight increase in body temperature, and that these weren't a epilepsy condition but rather a hereditary disorder that she would out grow by a early age. At 3 yrs old her seizures did stop, but by the time she started school there were neverending behavior issues that eventually got her placed in a alternate school for troubled kids and she was kicked out of that too. School district sent a tutor to our home and new problems started. She became attached to her tutor, even calling her a second mom. Wanted to go live with her and I stopped her tutoring and explained that her relationship with the tutor was not normal and unhealthy. My daughter showed signs of depression,loss of interest in everything, emotionally withdrawn. Spoke about self harm, and angry towards the household.angry one minute, hateful and mean next, have crying episodes and didn't always know why.both girls now grown and in their 30's and these disabilities are strongly intact. My oldest (32) denies she has disability issues, ADHD,anger , anxiety, severe mood swings, lost sense of reality, struggles still with Grammer,and understanding comprehension. Depression and says that she sometimes catches her talking to herself. Her sister (30) has disabilities and faces them , bi-polar very manic, severe depression and feels suicidal at times. Anxiety that can be severe. She has been mentally and verbally abusive towards me and her sister. She struggles with maintaining a healthy relationship with the father of her children. Both daughters have 4 kids each, my oldest grandson is lower spectrum autism, anger, pain sensation delay, can't not read, lower number counting, depression and behavioral issues. My younger daughter has a son and 2 daughters who battle with some reality loss, depression, anxiety,night terrors,her son mild autism. I truly feel both my daughters are autistic, a disability that wasn't heard about in 1990 and 1992. So who should be held accountable for the negligent dispersement of a medication the FDA warned against using in pregnant women and the fact it is for treatment of preterm labor. Because not only are my daughters living and suffering from the effects of terbutaline but their children are suffering from the negligence of the people responsible for poisoning me, thier mother, thier grandmother. Terbutaline alters your brains chemical balance, breakdown the serotonin levels. Someone needs to be held responsible for this.EVERY MOTHER ON HERE SHARING YOUR STORY AND THE PAIN AND SADNESS THAT THIS DRUG HAS CAUSED , WE ALL HAVE EXPERIENCED THEY SAME EXACT SIDE EFFECTS AND ALL OF OUR CHILDREN SHARE THE SAME EXACT EFFECT. AND YES I HAVE CONGESTIVE HEART FAILURE, DEPRESSION, ANXIETY, AND MORE. IM GOING TO LOOK INTO MAKING SOME ONE RESPONSIBLE FOR DESTROYING INNOCENT LIVES

Posted by

In 1993 I was given oral Breathine/Turbutaline for about 70 days in my 3rd trimester for premature labor. My son has had a number of emotional problems including anxiety and depression diagnosed as early as 9 years old. He has been diagnosed with ADHD as well. His emotional issues, I believe, had such an early onset that I have always felt that the medication did damage. Only recently, however, did I learn about the research pointing to the same conclusion.

Posted by

Hello I have a son who is 17 I was put on terbutaline most of my pregnancy and my son has been diagnosed with adhd and has learning disabilities bowel movement issues and severe outburst. I strongly feel this meds have caused his problen. He's been hospitalized for some of his issues. He's been put threw he'll with this it affects him everyday.

Posted by

I am 23 weeks and was in Labor & Delivery for contractions caused by UTI. I was given Breathine, 2 doses injected in my arm. I was curious how they can give me those if the fda does not approve usage in preventing uterine contractions?


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