You don't want to get it wrong.
It was back in February—almost a year ago—that the US Food and Drug Administration (FDA) issued its latest cautionary position for an indication that would have been furthest from the agency's collective brain trust when the drug was approved in 1994 for treatment of asthma and various bronchial issues.
Three years later, Terbutaline was being increasingly adopted off-label as a means to treat early or pre-term labor in expectant mothers. That left the FDA with the task of issuing warnings against the prolonged use of Terbutaline, over concern for Terbutaline side effects.
Fourteen years later, those warnings keep coming amidst some conflicting reports. The FDA has focused primarily on the health of the mother and warns against the use of Terbutaline beyond 48 to 72 hours through any means. Those delivery systems include injection, oral Terbutaline or by infusion pump. Serious heart problems and the risk of death in the mother are the concerns.
Pregnant women are torn between the risks associated to the baby through premature birth v. any potential for harm of the Terbutaline passing through the placenta. One woman writing to an online medical site, pregnancy.org, was concerned about potential Terbutaline side effects to her unborn child. A medical expert replied that while taking any medication while pregnant is never a good idea unless absolutely necessary, the responder was not aware of any research suggesting damage to the fetus beyond the potential for subtle effects long-term.
And yet in 2004 a study originating with Duke University Medical Center concluded that Terbutaline was a developmental neurotoxicant.
Translation: cognitive and neuropsychotic issues.
From mothers who have contributed responses to a Salient News summary of the February 2011 FDA warning, some interesting posts.
One woman took Terbutaline sulfate for the pre-term labor she experienced with both of her sons. Well beyond the FDA's outside limit of 72 hours, the patient was on Terbutaline for six weeks and nine weeks respectively. Her oldest, she says, is fine. But her youngest, "isn't." She didn't go into detail.
Another contributor said she took Terbutaline for eight to 10 weeks for her two children. Both, she reports, suffer from Terbutaline side effects.
READ MORE TERBUTALINE SULFATE LEGAL NEWS
Hence the concern about potential for autistic-spectrum disorder and other developmental issues given the capacity for Terbutaline sulfate to cross the placenta and blood-brain barrier of the fetus, according to the February 22, 2011 issue of the Salient News.
Doctors appear to remain divided, with some advising that use of Terbutaline during pregnancy carries less risk than that of a premature delivery. Others advocate exhausting every other avenue to control pre-term labor in order to avoid long-term use of Terbutaline sulfate (beyond 48 to 72 hours) to mitigate pre-term labor.
One Terbutaline mother posting to an online forum articulated the possibility of a Terbutaline lawsuit.