Did Terbutaline Cause Heart Defects in Newborn?

Washington, DCThe debate over Terbutaline Sulfate continues, with some doctors adamant that use of Terbutaline during pregnancy for the express purpose of stemming preterm labor is important to the viability of the child. Other doctors aren't so sure, whereas some parenting and pregnancy advocates approach Terbutaline with varying degrees of disdain.

As for the US Food and Drug Administration (FDA), the agency had never approved Terbutaline for preterm labor. However, its off-label use for that indication prompted the FDA back in late winter to issue a boxed warning with regard to the use of Terbutaline for prevention of preterm labor or for prolonged use. The suggestion is that when presented with sudden preterm labor, the use of Terbutaline off label would be acceptable in a limited capacity.

Prolonged use, however, is thought to increase the risk of serious Terbutaline side effects including the potential for heart problems and even maternal deaths.

Some health advocates are adamant when it comes to use of the Terbutaline drug for preterm labor. "The Preemie Primer" is a parenting blog that does not hide its disdain where it comes to Terbutaline—approved by the FDA as an asthma drug—and pregnancy.

Writer Jennifer Gunter blogged back in February that in her view Terbutaline just doesn't work. Gunter cites a number of studies (without identifying them) that suggest Terbutaline use affords no greater advantage than doing nothing at all when presented with premature labor. Yet the risks are great.

Gunter notes that the FDA black box warning isolating the use of injectable Terbutaline for preterm labor in the hospital cites a limitation of no more than 48 to 72 hours due to a risk to the mother's heart. To that point, Gunter notes that 16 women have died as the result of Terbutaline Sulphate use.

Gunter reminds us that it is the position of the American Congress of Obstetricians and Gynecologists that Terbutaline taken orally should not be "undertaken as a general practice."

The last word goes to Jessica, a mother who posted a heartfelt comment to the Preemie Primer on April 9 after giving birth to a Terbutaline side effects baby.

"I was given Terbutaline (injections and oral) for over a month," Jessica writes. "I finally stopped taking it because I couldn't sleep and couldn't drive because I was so shaky. My daughter still ended up being born 3 weeks early and she has congenital heart defects that required angioplasty at 2 months of age and open-heart surgery at 3 months.

"I have been assured by two surgeons and [my daughter's] cardiologist that this condition is not hereditary and it was not caused by anything I did during the pregnancy…there was no way I caused her heart condition…there is also absolutely no history of heart disease in my family. I would advise every pregnant mother to STAY AWAY from Terbutaline! (author emphasis)"

Terbutaline sulfate side effects will continue to be debated by health advocates and the medical community alike.