FDA data analysis reveals adverse drug combo

Widely prescribed drugs for depression and high cholesterol may raise blood sugar levels when taken together. The potentially adverse drug combo came to light through mining an FDA database and was confirmed in analyses involving animal experiments and electronic health records.

InformationWeek reports that the data mining study, covered in an article published in the Journal of the American Medical Association (JAMA), uncovered an increase in blood glucose levels in patients who were taking both the antidepressant paroxetine (Paxil) and the cholesterol-lowering drug pravastatin (Pravachol). The finding could have implications for up to 1 million patients in the U.S. who might be taking the two drugs.

Stanford University biomedical informatics graduate student Nicholas Tatonetti, who is lead author of the study, first published the findings online in May in the journal Clinical Pharmacology and Therapeutics. It's another example of how mining databases and electronic health records systems can catch dangerous drug reactions even before physicians and regulators.

"If a physician has a patient on these [two] medications and their diabetes becomes harder to control, the physician may want to consider changing the medications," said Dr. Russ Altman, a principal investigator of the study and a professor of bioengineering, genetics and medicine at Stanford, in the JAMA article.

The researchers found the potentially adverse combo with an algorithm applied to the FDA's Adverse Event Reporting System. InformationWeek reports that the algorithm hunted for "latent signals" of diabetes side effects, not the adverse events that were actually reported on the system.

- check out the InformationWeek article
- see the coverage in JAMA
- here's a link to the study published in Clinical Pharmacology and Therapeutics