Experts: Key Drug Facts Often Left Off FDA Labels

MATTHEW PERRONE

WASHINGTON (AP) — Did you know that Lunesta will help you fall asleep just 15 minutes faster? Or that a higher dose of the osteoporosis drug Zometa could damage a cancer patient's kidneys and raise their risk of death?

Chances are you didn't, and neither did your doctor. Much of what the Food and Drug Administration knows about a drug's safety and effectiveness is not included on the label, say two drug safety experts who are calling on the agency to make that information more accessible.

In this week's issue of the New England Journal of Medicine, researchers from Dartmouth College argue that drug labels don't reflect the nuanced decisions the FDA makes when deciding to approve a drug. The editorial from Drs. Lisa Schwartz and Steven Woloshin recommends easy-to-read fact boxes to help patients weigh the benefits and risks of medications.

If drug labels sometimes exaggerate benefits and play down drug risks, the authors say there's a very good reason: they are written by drugmakers.

While FDA must approve the final labeling, the actual language is drafted by the manufacturer, with input from FDA scientists.