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FDA Issues Black Box Warning for Terbutaline a Popular Pregnancy Drug

April 14, 2011

The FDA has just issued a black box warning for the drug Terbutaline, which is an asthma drug used to prevent pregnant women from going into premature labor. Terbutaline is sold under the brand names Brethine and Bricanyl. The FDA recently announced that the drug should now be counter-indicated for this "off-label" use of the asthma drug, and is requiring that the drug carry a black box warning, which is the strongest warning required by the FDA.

Terbutaline has been linked to serious side effect in pregnant women, including cardiac arrest, cardiac arrhythmia, hypertension, pulmonary edema and tachycardia. The new warning required by the FDA echoes concerns expressed by the FDA about serious heart problems related to use of Terbutaline by pregnant mothers in a letter sent to physicians by the agency in 1997. The drug Terbutaline has never been approved for "off label" use with expectant mothers to manage premature labor, but a drug approved by the FDA may be used by physicians for other uses they deem beneficial.

If you have suffered serious side effects including serious heart conditions or a loved one has suffered wrongful death, which may have been caused by the use of Terbutaline to prevent premature labor, you may have a right to seek compensation for your injuries. Contact the Georgia personal injury lawyers at Montlick and Associates, Attorneys at Law, for a free consultation to discuss your rights. Our Atlanta injury lawyers are dedicated to providing exceptional service as part of our goal to be the best Atlanta personal injury law firm in all of Georgia.

The FDA is warning that expectant mothers should not be given injections of Terbutaline for more than three days "because of the potential for serious maternal heart problems and death." The FDA has also warned physicians that the drug Terbutaline should not be prescribed for premature labor because it carries a similar risk and has not been shown to be effective in preventing premature labor. According to the FDA, the deaths of a dozen women have been linked to Terbutaline between 1998 and July 2009. Based on this data and a lack of evidence of the drug's effectiveness for preventing premature labor, the FDA has concluded that the risk of serious adverse events outweighs any potential benefit from the drug when taken by expectant mothers.

It has been estimated that Terbutaline is prescribed to over a million women per year to manage premature labor. The drug also penetrates to the unborn baby where it can have an adverse impact on the baby's brain development. Studies, including one conducted by Duke University, have linked Terbutaline during pregnancy to an increased risk of brain damage and cognitive deficits in infants. If you or your loved one has suffered serious side effects, which may be linked to use of Terbutaline, you may have a right to compensation for your injuries.

Our experienced Georgia dangerous drug lawyers are available to assist clients throughout all of Georgia and the Southeast, including but not limited to Albany, Athens, Atlanta, Augusta, Columbus, Gainesville, Macon, Marietta, Rome, Roswell, Savannah, Smyrna, Valdosta, Warner Robins and all smaller cities and rural areas in the state. No matter where you are located our attorneys are just a phone call away, and we will even come to you. Call us 24 hours a day/7 days a week for your Free Consultation at 1-800-LAW-NEED (1-800-529-6333). You can also visit us online at and use our Free Case Evaluation Form or 24-hour Live Online Chat.

Category: Personal Injury

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All information provided by our blogs is general in nature and should not be relied upon as legal advice. Consult a Montlick attorney for details about your unique situation.