FDA Warns Against Terbutaline for the Treatment of Preterm Labor

On February 17, 2011, The US Food and Drug Administration issued warnings to the public stating that injectable Terbutaline, a potent bronchodilator indicated for the treatment of acute airway narrowing, should not be used for the long term prevention of preterm labor. The FDA now recommends that Terbutaline be used (if at all for this off label purpose) for no more than 48-72 hours because of its potential to cause maternal cardiac arrhythmias (irregular and potentially deadly heart rhythms). Likewise, the FDA warns against using oral Terbutaline because it has not been shown to be efficacious in preventing preterm labor and has similar safety concerns as the injectable form. The FDA requires that all forms of Terbutaline (oral, injectable and subcutaneous pump) carry Black Box warnings and contraindications for use. The decision to require the addition of a Boxed Warning and Contraindication is based on new safety information received and reviewed by the FDA.

Terbutaline was first indicated and used for the treatment of acute bronchospasm for respiratory conditions such as asthma, bronchitis and emphysema in 1976. Terbutaline belongs to a class of drugs called Beta Adrenergic Receptor Agonists. The anticholinergic properties of the drug can cause dangerous and potentially lethal heart arrhythmias. As indicated for bronchospasm, typically once the acute airway narrowing has been reversed, Terbutaline is stopped and patients are switched to maintenance medications. Terbutaline was never intended for long term use.

Terbutaline became popular for the treatment of preterm labor in the late 1990’s when some cases of preterm labor appeared to respond to the drug. However, Terbutaline has not been efficacious across the board and studies of the drug in injectable, oral and even continuous infusion have shown no efficacy. Terbutaline, a vasoconstrictor, was thought to slow and subsequently halt contractions. However, no matter what the “supposed” effect, there is no medical evidence that Terbutaline, whether injected or taken orally, does anything to halt preterm labor. In 2008, The FDA issued a “Dear Colleague”response to a citizen’s petition, yet it is still being used for the treatment of preterm labor despite its potential for serious and even fatal cardiac complications. To date, 16 maternal deaths can be attributed to cardiac arrest as a result of Terbutaline administration.

It’s amazing to see that with all of the current data, some even amassed by the FDA itself, The FDA still has not come out and issued a complete halt to the use of Terbutaline as a tocolytic treatment for preterm labor. Why is this? With the known side effects, the fact that it is used off label and with the lack of evidence-based medicine to back it up, why hasn’t the FDA made the clear statement, “Do Not use Terbutaline in any form as a treatment for preterm labor?”

Perhaps the FDA feels that by prohibiting the use of Terbutaline, they will be reducing the number of treatments available for obstetricians to use with cases of preterm labor. But if this treatment has no evidence that it is efficacious, I fail to see the loss. We all know that treating women with preterm labor is tricky and the truth of the matter is that there are very few reliable, effective treatments. But the answer is not to continue using treatments without evidence of benefit yet with serious, potentially fatal side effects.

If the FDA, obstetricians and others are truly concerned that there aren’t enough efficacious treatments available for preventing preterm labor, I believe that their efforts would be better spent canvassing for support and funding for research for effective treatments rather than trying to make a clearly inappropriate treatment suitable.  How many more women (and perhaps babies) will have to lose their lives to Terbutaline treatment before we begin to look elsewhere for treatments for preterm labor?

Posted by: Darline Turner-Lee, MHS, PA-C

12 Comments

FDA Warns Against Terbutaline for the Treatment of Preterm Labor

July 9, 2012 07:00 AM by mome2
I know i am waaaaay late on this article but for other women who may come across it i just want to share my experience: I had cramping(contractions) from about 9 weeks till i delivered at 31 weeks after pprom. I was first given terb at 23 weeks. 5 shots, no dialation, contractions started immediately upon leaving the hospital again. I was sent back that afternoon, given terb every 3 hours for about 24 hours straight along withconstant iv fluids and some other med for contrax. Wasnt even told what it was, it was just injected in my iv. I was given a cerclage for cervical incompetence.....which is funny because i understood that cervical incompetence was characterized by dilation absent contractions...anyway. the cerclage seemed to cause even greater uterine irritability. Literally every week from 23 to 31 weeks i was back in l and d and every time i was given 3 to 5 shots of terb and eventually procardia and indomethacin combined. I was also given torodol in my iv and had to freak out on the nurse and make her call the dr to find out what the hell they were injecting into me!!! So in total i probably recieved between 30 and 40 shots of terb along with torodol, procardia, indo, and one or two drugs i never even knew the name of. At 29 weeks the peri ordered a terb pump for me. I flat out refused it. My ob said he understood my reasoning but recommended it anyway. The on call dr laugged in my face and refused to let me leave the hospital without it. I had to sign an ama form. The peri told me my insurance wouldnt cover it anyway but then marked me as a noncompliant patient!! The only person who was reasonable was a nurse who discussed the terb pump in depth with me and agreed that i shouldnt be a candidate for it. I had side effcts completely ignored and was treated like i was a monster. No one wanted to discuss risks or efficacy, it was their way or the highway. Not only did i have to deal with this from the hospital but now my refusal of the terb pump is even being used against me in a custody case...even after the fda warning. This is all just nuts to me and women need to start educating themselves and their drs if need be.

FDA Warns Against Terbutaline for the Treatment of Preterm Labor

January 25, 2013 07:00 AM by mary ingram, L&D RN
Just a note re: terbutaline not being approved for the treatment of preterm labor - none of the current "standard of care" medications currently used, i.e. magnesium sulfate, nifedipine, are FDA-approved. They are all being used "off-label", meaning a use different than the one for which they received FDA approval.

FDA Warns Against Terbutaline for the Treatment of Preterm Labor

January 21, 2014 07:00 AM by mommyd
This is a bit scary. I was on terbutaline in 2001 for my preterm labor starting week 22-37. When I was first put on it I was in the hospital for preterm labor told that my cervix was funneling and informed I had an incompetent cervix. When I was in hospital on terbutaline I felt like I was having a heart attack like my chest was being squeezed fron the front and back it was so painful I was given an ekg and a shot of morphine and switched to procardia for 2 weeks bit it wasnt stopping my labor along with strick bedrest. I switched ob gyn dr's at 24 weeks and then went into contractions like crazy. I went to the hospital and had my cerclaige the day after 9/11 attack. I was told i had a 25% chance of this working and this was my last chance for not deliverying. Anyway it worked not after being rushed in an ambulance from one hospital to another after the surgery because I started having an infection and they had a perinatal dept. I took that terbutaline pills every 3 hours for 10 weeks. My daughter was full term and I actually had to be induced because she wouldnt come out and I was dilated at a 3 for 3 weeks. My daughter is smart in some areas and not in others she struggles with memory and she struggled as an infant and up to 5 with rage and night terrors. She seems to struggle with motor stills like she couldnt button her pants till she was 10. She has a hard time still ting her shoes yet she is a wonderful artist she can draw animals in such detail and chartoon humans and animals. She had her art displayed in our mall at a art exhibit for 12 schools in our city and surrounding area. I . Wondered if her struggles are from the drug. I have huge sleeping problems from the drug and waking up ever 3 hours for 3months taking this drug and no I was never told about it not fda approved. I then 9 years was given thie drug but only 1 night when I started having contractions at 33 weeks. The dr didnt again ask me nor tell anything about the drug in 2010.

FDA Warns Against Terbutaline for the Treatment of Preterm Labor

September 14, 2014 07:00 AM by Nick
@Kimmelin Hull It worked well for my daughter. Kept her in the oven for another 3.5 months. She was born one day after we stopped treatment.

FDA Warns Against Terbutaline for the Treatment of Preterm Labor

September 14, 2014 07:00 AM by Nick
The magnesium sulfate was effective at stopping the early labor in our case. But it does relax every muscle in the body...

FDA Warns Against Terbutaline for the Treatment of Preterm Labor

December 5, 2014 07:00 AM by mommyA
@mommyd I can't tell you how much this article scares me to death. I went into pre-term labor with my youngest of 3, at 28 weeks. Was given turb through iv, and an overnight stay at the hospital until contractions stopped. 5 overnight stays (with turb given through iv)later and a prescription for bedrest & oral turb, my daughter finally came at 38 weeks. But must like mommyd's child above-was in labor for hours (almost 2 days to be exact). To top it all, I had a pregnancy induced heart condition (not just w/ 3rd child but 2nd as well) Innopropriate sinus tachycardia which gave me a very fast resting heart rate. Through turb on top of that and talk about a heart beating so fast my fast was red and I was out of breath with palpitations--yet my ob still prescribed it for pre-term labor like it was candy! NEVER ONCE was I informed of any risks--the only thing they said is that it would make my heart race and given I already had the heart condition, I asked if this was a good decision..my ob always assured me the benfits outweighed any risks. So here I was taking a beta blocker for my heart condition and turb and this was in 2008. I feel so foolish to just now be coming across this but it was only after talking to my nurse friend tonight, about my 3rd child who is SO hyped up all of the time that she mentioned a side effect of this drug. So now I am wondering about all the ways this could be effecting my daughter!! Would love if anyone could shed more light on this subject as far as long term effects on the baby for me.

I suffered from heart failure

September 22, 2015 07:00 AM by Patricia Longo
I suffered from heart failure on "turb and mag" in Honolulu in 1995, while in labor. Whole bus loads of women were told were a week early in our labor- and strong armed into it. My child, who was born that way, is autistic. So are a huge number of kids born at Kapi'olani Hospital in those days.

In July 2000, I was prescribed

November 13, 2015 07:00 AM by Catherine Bogdon
In July 2000, I was prescribed terbutaline in my 26th week of pregnancy for preterm labor, following an otherwise healthy, normal pregnancy. I can't recall what the dosage was, but when my contractions stabilized after a couple of days in the hospital, I was sent home to be on bedrest for ten weeks and was told to take the oral medication constantly until my 36th week (full term). At no time was I told about the possible short-term side-effects to me or the (more horrifying) potential long-term effects to my child. At no time was I told that the use of the drug was "off label." At 36 weeks I stopped taking the drug. My child stayed in-utero for another five weeks and I had a normal delivery. Unfortunately, my decision was based on fear and a lack of information. The woman in the room next to me was also in preterm labor at 26 weeks, and gave birth. The baby died. I am not saying that I would have NOT taken the drug at that point if I had the information I have now, but I would have drastically reduced the time period I was told to to take, requested more monitoring and possible "weaning off" the drug sooner. I definitely would have asked a LOT more questions about dosage and prolonged use. Unfortunately, now I have a 15 year-old daughter who is having severe emotional and cognitive issues, which studies have shown are becoming the "norm" for children whose mothers used long-term oral terbutaline in the late 1990s to early 2000s. We are currently planning neurological testing to see if there is a brain injury that is contributing to her difficult situation. I can't do anything now about my uninformed decision to drug myself and my child in the last trimester or pregnancy, but I can, and will, learn all I can and help to give the information to others who may not be getting it from their OB team.

Triplets!

October 4, 2016 02:27 PM by TMilles

Turbutaline pump worked great for me!!  I delivered at 33 weeks.  I went in to preterm labor at 27 weeks.  They all came out with wonderful weights and I can tell you that I now have 3 college athletes!!  I loved it and am have 3 perfect kiddos!  

oral terbutaline

December 6, 2016 05:00 AM by Sandy

In 1987 I went into labor at 30 weeks and after a round of mag sulfate I was sent home on oral terbutaline and took it for 6 weeks.  It did stop my labor and i deliverd a healthy baby at 37 weeks.  She has no adverse effects and I am very greatful.  I have recently developed high blood pressure and an irregular and rapid pulse with no significant family history of heart disease.  It is possible that the terbutaline damaged my heart but the effects were not apparent for many years.

Preterm labor

January 31, 2017 09:39 AM by Bee

I was prescribed oral terbutaline pills when I was about 20 weeks with both my children. I believe it injured my daughter's brain. She had issues with depression and 20 months ago she died by suicide. I blame this drug that was prescribed to me without all the facts approximately 23 years ago. My son on the other hand seems to be okay. I think it's a hit or miss as far as the effects it has on the unborn child(ren.)

 

 

Terbutaline / Brethine

July 11, 2017 07:29 PM by Dawn Mathurin

in 2002 I delivered twins via c-section.  Prior to their birth I had loss a triplet pregnancy and again a twin pregnancy due to an incompetent cervix and pre-term labor.  After an extensive hospital stay, cerclage, and questionable leaking membrane, I was finally sent home on a Brethine pump, bedrest and monitoring x4 months. The nurse would instruct me to bolus myself a dose of Brethine after I transmitted via telephone the monitored data. In my case, the benefits far outweighed the risks.  I have healthy, very smart, fraternal boy/girl twins.  My daughter is a straight A honors student.  At times her disposition is less than desirable but she is 15 going through puberty and hormonal changes ... normal development!  She is only interested in what interests her and has been stubborn since inutero.  My son is more cooperative but academically he's a "typical boy" his age as per the teachers and guidance counselors.  He too gets good grades and is smart.  Girls usually are smarter than boys anyway!  Their health is phenomenal!  I was more concerned of the long term effects the drug may have had on ME!  I am a registered nurse now but then I had not even decided on becoming a nurse.  I was prescribed this medication without being informed of the risks ... I'm grateful for its unapproved use for treating pre-term labor because I have two lovely children as a result of this use.  All medications have adverse effects, and every person does not experience all or any of these effects.  I am certain there are plenty that have benefitted from the use because they did not act as if I was the first person they were going to try this treatment with.  Additional cardiac monitoring or cardiac clearance may be required for some or all ... but many medications have resulted in unfavorable outcomes.  Medicine is not an exact science.  I am sorry for any that did not benefit from the use of this medication...

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