Terbutaline Side Effects Include Risk of Death for Pregnant Women: FDA

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U.S. drug regulators are warning doctors about the use of the asthma drug terbutaline for treatment of preterm labor due to the risk of fatal heart problems that have killed at least a dozen women since 1998. 

The FDA issued a terbutaline drug safety communication on Thursday saying that the asthma drug should not be used on pregnant women for the prevention or prolonged treatment of preterm labor. The agency is also requiring a black box warning be placed on the drug and is adding a contraindication for preterm labor use.

Terbutaline is approved by the FDA to treat airway restriction caused by asthma, bronchitis and emphysema. However, the drug is also popular among obstetricians and gynecologists to prevent preterm labor or to treat preterm labor that lasts for more than 48 hours. This off-label use has never been green-lighted by the FDA, but doctors are allowed to use drugs for any treatment they see as beneficial to their patient.

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The FDA has been concerned about the use of terbutaline by pregnant women since at least 1997, when it issued a “Dear Colleague” letter regarding concerns about heart problems that appeared to be linked to subcutaneous injections of the drug. Since that time, the agency has studied medical reports and other literature on the drug and has found that it is unsafe and ineffective in treating or preventing preterm labor. It has also been linked to the deaths of 12 pregnant women since 1998 and at least 16 since 1976.

The deaths of the pregnant women were linked to a number of terbutaline heart side effects, including cardiac arrhythmias, heart attacks, pulmonary edema, hypertension and tachycardia. The women were given oral terbutaline, terbutaline injections, or both.

The FDA recommends that patients understand that there could be serious situations where a healthcare professional determines that short-term use of the drug in a hospital setting could be necessary, but pregnant women should be aware of terbutaline side effects, including maternal heart problems and death, that have been associated with use of the drug to treat preterm labor.

Tags: Asthma Drug, Heart Attack, Terbutaline
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8 Comments

Arlene
I was given terbuline in a pill form at 22 weeks in 1992 when I was pregnant with twin boys. Then they put me on a pump. I delivered the boys at 36 weeks. They both struggle. As children they were diagnosed as ADD and then OCD. Baby A is worse then baby B, he is unable to socialize, work, and is now has a severe case of Scrupulosity OCD. I have had him committed involuntarily twice and he has gone twice voluntarily. Meds have not worked. He is very intelligent but is stuck with a debilitating mental state. I want him to try TMS treatments, but he is not able to get past his intrusive thoughts.
Jessica
I’ve been in the past been put with each pregnancy and after I used it,it causes me to be tacacardic. What are my options
Misty
I was 33 weeks and began having contractions so I went into the hospital. They gave me three injections of Terbutaline 30 min apart with the assurance it was safe for me and my baby. I went to my clinic appt 2 days later just to be told that my baby was having problems getting oxygen, I spent a half a day doing ultra sound and non stress test. he scored a 6 out of 10. I was told to come back in the morning to have another ultra sound and stress test for baby. I was also told to have a bag packed and be ready to go drive over 2 hrs for delivery of him. Thankfully he scored 8 out of ten however the stress test was not the greatest. Having to do this yet again after the weekend. I had no problem with his lungs until after this shot.praying he is not born with any side effects
Lisa
I was on Tributaline starting at 12 weeks into my pregnancy. This was back in 1986/1987. My doctor put me on it after losing a baby at 27 weeks and then my 2nd pregnacy I was on Ritodrine. I requested that when I got pregnant with my son but the Dr refused and wanted me on Tributalin Me( which is my 3rd Preganancy) My son has has so many problems starting with formula at birth..he would vomit up everything,…we had him on Nutramagin. He has always had problems with comprehending.. and now he is 26 years old and still suffering…I need help…
r shack
I was an athlete perfect condition, I had breathine shots and pills with all three of my pregnancies, in my second pregnancy I started having super ventricular tachycardia-had to go to E.R. to get dangerous shots to slow down my heart rate, I still have to do that, I have neuro cardio genic sycopy, bradycardia- a pacemaker, but yet at no time no one said hey it may be the breathine, im so pissed, and my 15 year old son has some of my conditions but yet we have no family history of this and I was in perfect health, and we will suffer the rest of our lives
K Henry
I was on terbutaline from about 22 weeks until 37 weeks and now my child has autism. I realize looking back that I did not need to take this medication because the contractions were not causing me to dilate and my son was born full term at 39 weeks.
S LaMay
I have a child w/ a prolonged QT heart problem diagnosed by her pediatric pulmonologist, and its wasn’t until recently that I thought it might be related to the terbutaline. My family has no history of any heart problems. Is there anyone else w/ heart problems that was on terbutaline?
L. Florida
I took this med and my daughter has heart problems. The providers express to me this wouldn’t effect my daughter but she is disable and have a ongoing heart condition. I pray daily she lives a full life this is scary!

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