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Experts say key facts are left off drug labels


Experts: key drug facts left off labels

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 the FDA must approve the final labeling, the actual language is drafted by the manufacturer, with input from FDA scientists. Woloshin and Schwartz recommend the FDA provide reader-friendly summaries of its drug reviews online to supplement industry-drafted drug labeling. A spokeswoman for the FDA declined to comment Wednesday.

Newark, N.J.

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Times wires

Experts say key facts are left off drug labels 10/21/09 [Last modified: Wednesday, October 21, 2009 11:19pm]
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