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Hazard Warning - Brethine and Methergine mix-ups

From the April 22, 2004 issue

If you treat obstetrical patients, we urge you to take action to avoid dangerous mix-ups between the pharmacological opposites, METHERGINE (methylergonovine maleate) and BRETHINE (terbutaline sulfate).



Since 2000, we've received numerous reports of injuries related to look-alike packaging of these products, and published two alerts (April 19, 2000 and April 17, 2003) warning healthcare providers about the risk of mix-ups. Both agents are frequently stored and used in labor and delivery settings, but for very different clinical reasons. Terbutaline is used to treat preterm labor, and methylergonovine is primarily used after delivery of the placenta to treat uterine atony, subinvolution, or hemorrhage. Since methylergonovine has abortifacient properties, it is contraindicated in pregnancy and would be especially dangerous to a patient in preterm labor. Both of these products are packaged as 1 mL ampuls within an amber plastic tub covered by a foil label with the product name in tiny print, making them difficult to tell apart (photo appears in the PDF version of the newsletter). Both ampuls also have similar colored "rings" around the ampul necks that can be seen through the amber plastic, which further adds to their similarity. With so many risk factors, these medications are prone to being interchanged.

Interchanging these two drugs could result in serious adverse outcomes for the mother and baby. In one reported case, four doses of Methergine were administered to a patient in preterm labor, which was believed to contribute to fetal demise. In another case reported last week, a 35-year old female was experiencing significant preterm uterine contractions. Her physician diagnosed fetal distress and asked a nurse to administer terbutaline IV push. Instead, the nurse accidentally administered Methergine. The mother experienced significant contractions requiring an emergency C-Section. Fortunately, the patient and newborn were discharged 2 days later unharmed.

Until 2001, Novartis packaged both drugs; then aaiPharma acquired Brethine from Novartis. To our knowledge, no packaging changes have occurred since our initial report in 2000, and neither company has alerted the obstetrical community about the risk of errors.

Mothers and infants are still at significant risk for harm, so please keep staff informed about the potential for errors and store these products separately. Methergine ampuls should be refrigerated, which will help separate the products. Errors are still possible, though, so be sure to apply label reminders to the ampuls to prevent mix-ups.

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