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Health Organizations Issue Warnings about Use of Terbutaline during Pregnancy

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Baltimore, MDThe 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.

The American College of Obstetricians and Gynecologists has recommended against the use of injectable terbutaline to prolong labor for more than 48 to 72 hours, supporting a warning issued by the FDA about possible terbutaline side effects. Among the concerns regarding prolonged use of terbutaline during pregnancy are the possible increased risks of cardiac or cardiopulmonary arrhythmias, or pulmonary edema or myocardial ischemia in the mother.

Terbutaline has been used for longer than 72 hours to prolong labor and prevent preterm birth, an off-label use of the medication. The drug was originally approved to treat and/or prevent narrowing of the airways associated with asthma, bronchitis and emphysema.

On February 17, 2011, the FDA issued a warning that the risk of serious adverse events linked to prolonged use of terbutaline outweighed the potential benefits of the medication. The FDA announced that the drug would be given a new Boxed Warning and Contraindication on the label to alert health care professionals about the risks. The FDA noted that pregnant mothers could be at an increased risk of heart problems and even death.

According to the FDA, injectable terbutaline should not be used for more than 48 to 72 hours to treat preterm labor. Furthermore, oral terbutaline is not to be used at all to treat preterm labor because it has not been proven to be effective. Finally, the FDA warned that terbutaline should not be used in the outpatient or home setting.

The FDA had previously warned about the use of terbutaline during pregnancy. In November 1997, the agency issued a Dear Colleague letter to alert health care professionals about the potential risk. Between 1976 and 2009, 16 maternal deaths were linked to the use of terbutaline. A further 12 cases of serious maternal cardiac events were also reported.

In a letter issued February 17, 2011, in response to a citizen petition concerning terbutaline, the FDA noted that the drug has been reclassified from pregnancy risk category B to pregnancy risk category C.

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READER COMMENTS

Posted by

on
I went in to pre term labor at 25 weeks and was on magnesium in the hospital for a week and sent home on total bed rest and could only lay on right or left side. Spent 10 weeks on very high doses of subcutaneous terbutaline in my home. My son had either a stroke or seizure while with the nurses 45 minutes after birth, witnessed by my husband when his blood glucose dropped. I was only told they gave him glucose and fed him because of low blood sugar and low body temp. He was born at 37 weeks and was 6 pounds. He walked late at 16 months and was amazing with verbal and was very smart. I was told when he was 5 that he had been misdiagnosed. the doctors the Shriners brought here said he had Cerebral Palsy and left side hemiparesis. That explained why sports and anything he needed both left and right side for was a struggle. He was always hard to get him to focus and organized yet he was a very good reader and good with verbal. Once he went to college he really struggled and all the issues he was having ended up being Frontal to temporal lobe Epilepsy. The Neuro Psychologist said his issues were neuro based. He is 26 and still struggles. My question is. Why did they use that drug for 10 weeks at my home with a terbutaline pump when I could have stayed at the hospital on Magnesum if the FDA had sent out cease and desist letters by then? I did not know it was an off label use of the drug. I saw one of the letters by the FDA in 1991. He was born in 1990. I also saw a report from 1989 that said this drug caused hemiparesis in the babies. The FDA contacted me three times and wanted me to drag this all out when my son was ten. That was before I knew he was going to have struggles his whole life and before he was diagnosed with Epilepsy. When will they stop using this drug long term for pre term labor? I think there are way more issues with these children and many are adults now. No excuse that it took this long and they are still questioning. That is because it is cheaper to send moms home on this drug than keeping them in the hospital on magnesium. Shame on us all for not doing better research and really getting to the bottom of this.

Posted by

on
I was diognosed with pre term labor with my son in Sept. 1990. At that time I was 26 weeks pregnant. I was prescribed Terbutaline by my doctor to be taken orally every four hours around the clock to stop the contractions. I was also on bedrest. My son was born on his due date in January 1991, a healthy 9 lbs. I, however, hemorraged after a having a cesarean birth. I almost lost my life and was diagnosed with Sheehans Syndrome after the birth. Apparently my body went into shock from the blood loss, and my pituitary gland died. I have been on cortico steroids everyday since.
My son, now 26, suffers from Crohn's disease and has skin problems. Can all this be caused from the Terbutaline? I have been reading the health problems on this blog, and they all seem to be similar.

Posted by

on
I was diognosed with pre term labor with my son in Sept. 1990. At that time I was 26 weeks pregnant. I was prescribed Terbutaline by my doctor to be taken orally every four hours around the clock to stop the contractions. I was also on bedrest. My son was born on his due date in January 1991, a healthy 9 lbs. I, however, hemorraged after a having a cesarean birth. I almost lost my life and was diagnosed with Sheehans Syndrome after the birth. Apparently my body went into shock from the blood loss, and my pituitary gland died. I have been on cortico steroids everyday since.
My son, now 26, suffers from Crohn's disease and has skin problems. Can all this be caused from the Terbutaline? I have been reading the health problems on this blog, and they all seem to be similar.

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