Can ‘Big Data’ Help Increase Drug Safety?

October 9, 2013
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Researchers use an EHR database to reduce adverse effects

Using the Food and Drug Administration's Adverse Event Reporting System (FAERS), a hospital electronic health records database, and an animal model, a team of researchers at the Icahn School of Medicine at Mount Sinai report that by adding a second drug to the diabetes drug rosiglitazone, adverse events dropped enormously. That suggests that drugs could be repurposed to improve drug safety, including lowering the risk of heart attacks. The research is published online Oct. 9 in the journal Science Translational Medicine.

 “Big data systems have a wealth of data, and when studied appropriately, can point to potentially safer combinations,” said Ravi Iyengar Ph.D., professor of pharmacology and director of the Systems Biology Center at the Icahn School of Medicine at Mount Sinai. He said that findings from big data analyses, although preliminary, can point to potentially safer combinations that can subsequently be tested in clinical trial. “We may be able to use FDA-approved drugs to prevent adverse events,” he said

In this study, investigators studied how drug combinations act through networks within cells, focusing on the diabetes drug rosiglitazone, an effective drug in controlling blood glucose. However, rosiglitazone has a serious side effect, increased heart attacks, which have restricted its use markedly. Investigators analyzed data from the FDAERS to see if second drugs could lower the rate heart attacks, and compared their results with Mount Sinai's electronic health records system. They found that the drug exanatide, often given along with rosiglitazone to get better control of blood glucose, also very substantially reduced the heart attack rate in rosiglitazone users. Iyengar’s team also found nearly 19,000 other drug combinations in the FDA database, where the second drug appears to reduce a wide range of side effects of the first drug.

The research team said that that the results are a valid starting point for developing clinical trials of safer drug combinations, and urged researchers and clinicians to contribute to big databases, such as the FDA’s Adverse Event Reporting System.