Why isn't terbutaline approved by the fda for preterm labor?

Side effect profile. Terbutaline can block the uterine contractions of the final common pathway leading to preterm labor, however it does nothing to address the etiology of preterm contractions and has significant and potentially life-threatening maternal side effects with tachycardia, hyperglycemia and arrhythmias. There is little evidence that terbutaline (a brochodilator by design) is useful for long-term tocolysis.
Terbutaline. To approve a drug for a specific indication, the drug must be studied for that indication. The manufacturer of terbutaline would then present the data from the clinical studies to the fda for approval. The fda would then review the data and make a decision to approve or not to approve the drug for that indication. These steps have not occurred, so the drug is not approved.

Related Questions

Are there bad effects on a mother and baby when treated for preterm labor with terbutaline?

Unlikely. Terbutaline has a short half life and thus is excreated quickly. The effects are usually felt within minutes. Read more...
Usually Not. Terbutaline can make you feel shaky & jittery. We used to titrate or adjust the dose by checking the patient's heart rate. It rarely causes complications but is now only used for short term treatment. It's not recommended if there any heart problems or conditions that can be worsened with an increased heart rate. Most obs are using this med less than before. Read more...
Not really. This is a chemical cousin of adrenalin, a normal stress chemical made by your body. It is quick acting but out of your (babies) body in 8 hours or less. Other than give you a headache and raise your heart rate & make you edgy, it has minimal side effects. Read more...

I was wondering what are the effects on a mother and baby when treated for preterm labor with terbutaline?

Rapid heart rate. Mom may experience a rapid heart beat which may cause changes in the baby 's heart rate as well. That is the most common change and is short lived if the medication is not continued. Read more...

My doctor prescribed terbutaline for my "comfort" I was not in preterm labor. I never dilated nor had any effacement. Why?

Not in labor. You likely didn't dilate because you weren't in preterm labor. There are no medications that will stop true preterm labor; the best we can do is slow things down to allow benefit of steroids to improve lung maturity. Current guidelines recommend against the use of medications beyond 48 hours for slowing contractions, there is no demonstrated benefit that justifies the risks of these medications. Read more...