chapter  16
22 Pages

An Integrated Approach to Assessing Drug-Drug Interactions: A Regulatory Perspective

Change in one or more safety and efficacy outcomes of a drug by concomitant administration of another drug that interacts with it has become of increasing interest in the last decade. This increased interest has arisen in part because of many documented adverse clinical consequences of drug-drug interactions, coupled with improved understanding as to their cause. Interest in drug-drug interactions has also increased because of the rise in polypharmacy, where patients may take many drugs in the course of a day. The following regimen would not be uncommon today in patients over 50 years of age-one or more antihypertensive agents, aspirin, a lipid-lowering drug, a hypnotic, an antihistamine, an antidepressant, one or more oral hypoglycemics, a proton pump inhibitor, an NSAID, and, if the patient is female, a drug to prevent osteoporosis and hormone replacement therapy might be used. Depending on various shortterm conditions, an antibiotic or antifungal might be used.