Using FDA Big Data and Electronic Health Records to Improve Drug Safety

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, according to the press release. However, rosiglitazone has a serious side effect, increased heart attacks, which has restricted its use markedly. Since most patients with diabetes take more than one drug and the FDA Adverse Event Reporting System (FDAERS) is freely available, "investigators analyzed data from the FDAERS to see if second drugs could lower the rate heart attacks. In addition, investigators compared their results with Mount Sinai's electronic health records system." Compared with many other commonly used second drugs, "we 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," said Dr. Iyengar. Using these findings, the investigators made some predictions of how these beneficial drug interactions might work in diabetic mice, finding that the heart attack rate declined. "The beneficial effects of rosiglitazone and exanatide are not unique," explained Dr. Iyengar. "We 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. Other beneficial effects were demonstrated when lisinopril was added to a statin, where the rate of statin-associated rhabdomylosi...
Source: Policy and Medicine - Category: Health Medicine and Bioethics Commentators Authors: Source Type: blogs