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

METHYLERGONOVINE MALEATE AND THE RISK OF MYOCARDIAL ISCHEMIA AND INFARCTION

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.

1.http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm307608.htm,

SOAP 2013