Case Info
Terbutaline Use in Pregnant Women May Increase Risk of Autism
Asthma medication Terbutaline, received FDA approval in 1974 and was initially sold under the brand name, Brethine, by manufacturer, Novartis. It was widely used as an off-label medication for the treatment of tocolysis or pre-term labor in pregnant women. Up to 260,000 women per year may have been prescribed terbutaline during pregnancy.
In 2011, Brethine’s manufacturer, Novartis, was required to add a black box warning to their medication, advising against both oral and longer-term injectable terbutaline use in pregnant women. A black box or boxed statement warning is the strongest warning that can be issued by the U.S. Food and Drug Administration.
Though the medication was never approved to treat premature labor or prevent premature birth, the manufacturer may have known about the risks of the medication and continued to sell the medication or in some cases, may have promoted it for preterm labor.
Brethine’s Manufacturer May Be Held Accountable for Injuries Caused by the Generic Medication Terbutaline
In 2001, Novartis’s patent on Terbutaline expired and the company sold the brand name Brethine to another manufacturer. Since that time, Terbutaline has been sold by multiple manufacturers, under the name Terbutaline or other brand names, including Brethaire and Bricanyl. However, at least one court has determined that Novartis may still be held accountable for injuries caused by generic forms of Brethine even though the brand name medication was discontinued.
Research has shown that terbutaline use during pregnancy may increase the risk of autism diagnosis in children.
Children and adults who were diagnosed with autism spectrum disorder and whose mothers took terbutaline while pregnant may be eligible for compensation.