Lawsuit Contends Drug Caused Brain Damage In TwinsMay 21, 2004 | www.thewbalchannel.com
Last month, a lawsuit was filed that got the attention of many obstetricians and gynecologists and their patients.
It involves terbutaline a drug commonly prescribed to treat preterm labor and one a local mother claims caused her twin's brain damage. WBAL-TV 11 News health reporter Donna Hamilton reported this may become a huge controversy for pregnant women and their doctors.
Travis and Tyler Ring are fraternal twins who appear to be healthy normal 3-year-olds.
"Neither one of them speaks," said their mother, Karen Ring. "They're not able to spoon feed themselves yet."
Both boys suffer from brain damage. Their mother said she first knew something was wrong when Travis and Tyler were around 1. Doctors did all kinds of tests.
"Genetic metabolism, organic, MRI, CT scans," said Karen Ring. "All tests coming back normal."
That's when she started looking into terbutaline also known as Brethine the drug was used to stop her labor when she was pregnant with the twins. Her research led her to a Duke study on lab rats. It suggests the drug enters the fetal brain, and could potentially cause problems.
"Why did this lawsuit attract so much attention?" said Hamilton. "Because for decades, terbutaline has been routinely prescribed for millions of pregnant women to stop preterm labor."
And terbutaline's drug insert says it should be used during pregnancy only if the potential benefits justify the potential risk to the fetus. Weltchek says a pregnant woman has a right to know.
Terbutaline is approved by the Food and Drug Administration for asthma. For pregnant women, it helps stop contractions of the uterus, but in pregnancy the drug is used "off label," which means it's never been FDA approved for that use.
That's the heart of this lawsuit. Karen Ring claims she was not told by her doctors that terbutaline was being used off label.
"Basically, every drug is being used off label and we as physicians don't tell patients," said Dr. John Elliott. "That's not meaningful to them. Look, we're giving you prenatal vitamins. They're being used off label. That's not a meaningful conversation."
Elliott is the director of maternal fetal medicine at Banner-Good Samaritan Medical Center in Phoenix and he's been published for his research on multiple pregnancies.
"I believe that with all the information we have, doing research in humans and looking at lab data in animals, there's nothing to indicate terbutaline causes any harmful side effect in humans," said Elliott.
Hamilton said terbutaline is used in two ways. It is used as a first-line intravenous therapy to stop labor in the hospital, but some doctors also use it for what's called maintenance when a woman goes home. Hamilton said it is taken in pill form at a much lower dose in the second case.
But some studies say it's not effective used as a maintenance dose. So why expose the fetus to it?
Elliott says the point of oral terbutaline is to reduce the number of contractions, and while he says it won't stop a true episode of preterm labor, it may reduce unnecessary visits to the hospital and anxiety.
What Karen Ring knows is the prognosis of her two sons is uncertain.
"I know I did all the right things," she said. "I took extra care of myself. I knew I was carrying twins. I was extra, extra careful." Elliott says this case could have far-reaching consequences for doctors and patients.
"Without any scientific basis, we could end up with a medication that would not be used for something we know is harmful preterm delivery," said Elliott.