Obesity experts spotlight safety gap in clinical trials and drug labeling for people with obesity

First, the FDA should revise its Clinical Trials Guidance Documents and Regulations Relating to Good Clinical Practice to require testing on people with obesity.
Second, whenever appropriate, drug manufacturers should include information on the effects of obesity on specific drugs in the drug package insert.
Third, a reporting system for adverse events relating to drug metabolism in people with obesity should be established to enable the FDA and drug manufacturers to identify and track issues.