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When approved in 1994, terbutaline sulfate entered the market as a medication for treating asthma, bronchitis, and emphysema. Yet, as early as the 1980s, doctors adopted the drug for off-label usage in treating slow labor.
Over the years, patients experienced damaging and life-threatening side effects because of the latter usage, including heart issues and death. As well, children exposed to terbutaline sulfate have developed cognitive difficulties.
How It Works and Side Effects
Through the FDA-approved usage, terbutaline sulfate relaxes the bronchial tubes to ease symptoms. During preterm labor, the drug has a similar effect on the uterus. Roughly 1 million are now prescribed terbutaline sulfate to ease early contractions; previously, doctors used ritodrine to lessen this condition.
Yet, when doctors administer terbutaline sulfate, patients receive double the recommended dose – 15mg per 24-hour period. Some have experienced life-threatening side effects in response:
- Chest pain
- Pulmonary edema
- Rapid or irregular heart rhythm
- Increased blood pressure
- Lowered calcium and potassium levels in the blood
- Liver toxicity
- Increased blood sugar
Cardiovascular risks aren’t new, however. In 1980, the American Journal of Obstetrics and Gynecology pointed out a relationship between terbutaline sulfate usage and cardiovascular complications.
The mother isn’t the only one affected. In 2013, a Duke University study, published in the Journal of the American Medical Association, noted exposure to terbutaline sulfate leaves infants’ brains susceptible to cognitive deficits, including speech delays, movement disorders, and autism spectrum disorders.
Researchers found the drug crosses the placenta to then simulate nerve receptors in fetal tissue. As a result, babies in utero may develop neurological and cardiovascular deficits.
As early as 1997, the FDA warned about prescribing terbutaline sulfate for easing preterm labor symptoms.
By 2011, because of multiple safety reports filed, the organization required it to display a black box warning, stating that if terbutaline sulfate is administered by injection or infusion, pregnant women should not be exposed to it beyond 48 to 72 hours. Exceeding this limit increases risks of heart problems and death.
Since the FDA’s warning and the studies that followed, patients have come forward to speak about the side effects and to file lawsuits. Currently, no multi-district litigation or class action lawsuit is pending.
Think you experienced these side effects during preterm labor but are unsure whether you were given terbutaline sulfate? The drug goes by a number of names: