Commentary: Manufacturers’ Failure to Act on Risks of Terbutaline in Premature Labor Led to FDA Warnings

The Food and Drug Administration on February 17, 2011 issued its strongest warning against the use terbutaline, a drug frequently prescribed to prevent preterm labor, saying it appears to be ineffective at delaying premature births and poses serious health risks for pregnant woman who take it for longer than 72 hours.

Terbutaline, commercially marketed as Brethine and Bricanyl, is a drug approved for the treatment of asthma and chronic obstructive pulmonary disorder, sometimes called emphysema. It relaxes bronchial tubes and is used to ease asthma symptoms. But it is also thought to relax smooth muscles, including the uterus, thereby disrupting contractions in women who have gone into labor too soon. Although widely administered in hospitals as an injection or infusion to forestall labor, physicians also prescribe it in pill form to prevent premature labor in women who are carrying multiple fetuses or have a history of preterm labor.

FDA Reclassifies Terbutaline due to Pregnancy Risk

The FDA action came in partial response to a Citizen’s Petition received by the Agency on June 18, 2008. In that Petition, the FDA was asked to reclassify the pregnancy risk category for terbutaline sulfate to a higher “pregnancy risk category,” require manufacturers to revise their labeling to reflect the change in pregnancy risk category, notify obstetricians of the reclassification of the drug, the labeling change, and the recommendation of the National Asthma Education and Prevention Program, issue a “Dear Colleague” letter regarding continuous subcutaneous terbutaline pump therapy (CSQT), alerting health care professionals that it has not been demonstrated to be effective and is potentially dangerous to both the mother and the fetus, and require all providers of the “terbutaline pump” to report all past and future maternal deaths associated with use of the “terbutaline pump” to FDA. Additionally, require long-term follow-up of adverse events in exposed offspring of treated women.

On February 17, 2011, FDA Responds Terbutaline Citizen Petition. The Agency reclassified the “pregnancy risk” associated with terbutaline and required manufacturers of the drug to revise their labeling accordingly. More important, FDA notified the manufacturers “that the risks of using terbutaline sulfate … must be described in the labeling of the product, and we believe that the risks should be included in a boxed warning and a contraindication for prolonged or maintenance tocolysis [use in preterm labor].” So-called “black-boxed warnings” are reserved for drugs whose risks are especially significant.

Questions continue to linger concerning the delay between the submission of the Citizen’s Petition and recent FDA action to enhance warnings to obstetricians. According to FDA, its Fertility and Maternal Health Advisory Committee “reviewed and discussed available literature on the safety and effectiveness of terbutaline” in the management of preterm labor as early as 1993. Pursuant to recommendations made by the Committee, FDA “encouraged” manufacturers of the drug to conduct appropriate clinical trials and to apply to the Agency for approval of intravenous terbutaline for the acute treatment of preterm labor “under limited circumstances.” According to the FDA “no such application has been approved.” Yet, the drug continued to be used for such purposes, apparently with knowledge of manufacturers, even though, as FDA has noted, “there are demonstrated maternal risks associated with the use of terbutaline sulfate for prolonged or maintenance tocolysis.” Indeed, an FDA review of adverse events associated with the drug found a total of 16 fatalities as well as 12 “serious cardiovascular events” associated with use of the drug in premature labor.

Terbutaline is available in both oral tablet and injectable formulations. Currently approved and marketed oral and injectable terbutaline sulfate drug products include oral tablets manufactured by Impax Labs and by Lannett) and injectable versions manufactured by Bedford, Teva Parenteral Medicines, Inc., APP Pharmaceuticals, Akorn, and Hikma Farmaceutica). The oral and injectable formulations of terbutaline sulfate were originally marketed as Brethine and as Bricanyl.

Do I have a Terbutaline Lawsuit?

The trial lawyers at The Senators (Ret.) Firm, LLP have decades of experience navigating through complex legislative and regulatory issues and litigating high stakes cases all over the nation. Our law firm focuses on the representation of plaintiffs in Terbutaline lawsuits. We are currently accepting new cases in all 50 states.

If you or a loved one has been injured or killed after receiving a Terbutaline injection or infusion pump transmission, you should contact our lawyers immediately for a free confidential case evaluation. You may be entitled to compensation for your injuries and we can help.