Dan Roden
Faculty Member
Last active: 2/8/2016

Detecting drug interactions from adverse-event reports: interaction between paroxetine and pravastatin increases blood glucose levels.

Tatonetti NP, Denny JC, Murphy SN, Fernald GH, Krishnan G, Castro V, Yue P, Tsao PS, Tsau PS, Kohane I, Roden DM, Altman RB
Clin Pharmacol Ther. 2011 90 (1): 133-42

PMID: 21613990 · PMCID: PMC3216673 · DOI:10.1038/clpt.2011.83

The lipid-lowering agent pravastatin and the antidepressant paroxetine are among the most widely prescribed drugs in the world. Unexpected interactions between them could have important public health implications. We mined the US Food and Drug Administration's (FDA's) Adverse Event Reporting System (AERS) for side-effect profiles involving glucose homeostasis and found a surprisingly strong signal for comedication with pravastatin and paroxetine. We retrospectively evaluated changes in blood glucose in 104 patients with diabetes and 135 without diabetes who had received comedication with these two drugs, using data in electronic medical record (EMR) systems of three geographically distinct sites. We assessed the mean random blood glucose levels before and after treatment with the drugs. We found that pravastatin and paroxetine, when administered together, had a synergistic effect on blood glucose. The average increase was 19 mg/dl (1.0 mmol/l) overall, and in those with diabetes it was 48 mg/dl (2.7 mmol/l). In contrast, neither drug administered singly was associated with such changes in glucose levels. An increase in glucose levels is not a general effect of combined therapy with selective serotonin reuptake inhibitors (SSRIs) and statins.

MeSH Terms (25)

Adverse Drug Reaction Reporting Systems Aged Age Factors Algorithms Blood Glucose Cohort Studies Data Mining Diabetes Mellitus Drug Interactions Electronic Health Records Ethnic Groups Female Homeostasis Humans Hydroxymethylglutaryl-CoA Reductase Inhibitors Male Middle Aged Paroxetine Pravastatin Retrospective Studies Serotonin Uptake Inhibitors Sex Factors Socioeconomic Factors United States United States Food and Drug Administration

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