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///2013 Abstract Details
2013 Abstract Details2019-08-02T16:57:45-05:00


Abstract Number: O2 1
Abstract Type: Original Research

Brian T Bateman MD1 ; Krista F Huybrechts MS, PhD2; Sonia Hernandez-Diaz MD, DrPH3; Jun Liu MS4; Jeffery F Ecker MD5; Jerry Avorn MD6

Background: Methylergonovine maleate (Methergine) is a semi-synthetic ergot alkaloid that is commonly used to treat uterine atony. In 2012, based on spontaneous reports, the U.S. Food and Drug Administration identified a “potential signal of serious risk/new safety information” regarding myocardial ischemia and infarction associated with methylergonovine-induced vasospasm(1). We therefore examined the risk of acute coronary syndrome (ACS) and acute myocardial infarction (AMI) associated with methylergonovine use in a large database of inpatient delivery admissions in the United States.

Methods: We conducted a retrospective cohort study using data from the Premier Perspective Database, and identified 2,233,630 women hospitalized for delivery between 2007 and 2011 (approximately one-seventh of all U.S. deliveries during this period). Exposure was defined by a charge code for methylergonovine. Study outcomes included acute coronary syndrome (ACS) and acute myocardial infarction (AMI) defined using validated diagnostic codes. Propensity score matching with a fixed 1:1 ratio was used to address potential confounding caused by differences between those exposed and unexposed to methylergonovine in demographic characteristics, obstetrical/medical conditions, markers of the presence, etiology, and severity of obstetric hemorrhage, and characteristics of the hospital at which delivery occurred.

Results: Methylergonovine was administered to 139,617 (6.3%) patients. Overall, 6 patients exposed to methylergonovine (0.004%) and 52 patients unexposed to methylergonovine (0.002%) had an ACS. Four patients exposed to methylergonovine (0.003%) and 44 patients in the unexposed group (0.002%) had an AMI. After propensity score matching, the relative risk for ACS associated with methylergonovine exposure was 1.67 (95% CI 0.40 – 6.97) and the risk difference was 1.44 per 100,000 patients (95% CI -2.56, 5.45); the relative risk for AMI associated with methylergonovine exposure was 1.00 (95% CI 0.20 – 4.95) and the risk difference was 0.00 per 100,000 patients (95% CI -3.47, 3.47). None of the cardiac events in the methylergonovine group resulted in in-hospital death.

Conclusion: Despite studying a very large proportion of U.S. deliveries, we did not find a statistically significant increase in the risk of ACS or AMI in women receiving methylergonovine compared with those who did not; estimates were increased only modestly or not at all. The upper limit of the 95% confidence interval of our analysis suggests that treatment with methylergonovine would result in no more than 5 additional cases of ACS and 3 additional cases of AMI per 100,000 exposed patients. Clinicians must balance this very small potential increase in absolute risk with the established benefit of methylergonovine in treating uterine atony.


SOAP 2013