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Updated 2/24/01
- Terbutaline and magnesium sulfate are not FDA-approved for use as preterm labor drugs. They are used "off label" for this purpose. In fact, virtually every drug used for preterm labor is used "off label" since Ritodrine's manufacturer took it off the market. Ritodrine was FDA-approved for preterm labor.
- At least 10 studies since the early 1980s reveal that terbutaline works no better than a placebo or no treatment in prolonging pregnancies after a period of 24-48 hours.
- Despite its use since 1969, few placebo-controlled or controlled studies have been done on whether magnesium sulfate actually works. The two published studies that used a placebo control or no treatment found that it worked no better than a placebo.
- Nifedipine (aka Procardia) is thought to be better tolerated than terbutaline and mag sulfate. In comparisons with Ritodrine (a sister drug of terbutaline), nifedipine worked better with fewer side effects. However, its long-term use has not been well studied and in a 1999 study it failed to prolong pregnancies any better than no treatment at all after contractions were stopped with magnesium sulfate.
- Terbutaline, an asthma drug, has been associated with some serious side effects/complications in pregnant women. These include chest pain, fast heart rate, arrythmias, peripartum cardiomyopathy, low blood sugar, low potassium levels, elevated liver enzymes and deaths.
- Magnesium sulfate is given in such high doses for preterm labor that the line between an "effective" and toxic dose is quite thin. An overdose of magnesium sulfate can be fatal to the mother. Meanwhile, two studies link its use to deaths of fetuses and newborn babies. The latest study from 2000 says the risk is especially great when high doses are used (greater than 48 grams) and the fetus/baby is tiny (about 1.7 to 2.7 lbs). The risk of death is 4.7 greater in these high doses than in doses less than 48 grams.
- Combining preterm labor drugs can be dangerous.
- Very little research has been done on the long-term effects on children whose mothers took terbutaline while they were pregnant.
- High doses of steroids (such as betamethasone) have been successfully used to mature the lungs of babies before delivery when their mothers experience preterm labor. However, studies were only done using one course of steroids. No studies have assessed the safety or efficacy of using multiple courses of steroids, which can be common when a woman is far from term. A study in Israel found women receiving multiple courses of steroids were more likely to suffer infections, some of them life-threatening.
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