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FDA Faults Drug Information for Consumers
Date:12/16/2008

nd less than one in 10 leaflets met the criteria set for legibility and comprehensibility, Seligman said. "Leaflets for the same drug ranged from as few as 33 words to as many as 2,400 words, depending on the pharmacy where the information was distributed," he said.

The researchers evaluated the consumer information provided by 284 pharmacies for two drugs -- metformin, a diabetes drug used to lower blood sugar, and lisinopril (Prinivil), a medication for high blood pressure.

Seligman said there has been some improvement since the last FDA study, done in 2001, which found that 89 percent of patients received written information with their new prescriptions. But only about 50 percent of the information met the minimum standards for consumer usefulness.

To solve these problems, the FDA's Risk Communication Advisory Committee will hold a public meeting early in 2009 to discuss the study's findings. Also, the agency has created a Web site where the public can comment on the study and offer suggestions on ways to provide better prescription information.

The study was conducted by the University of Florida College of Pharmacy under a $350,000 FDA contract.

More information

To learn more about the new study and to offer comments, visit this FDA Web page.



SOURCES: Dec. 16, 2008, teleconference with Paul Seligman, M.D., M.P.H., associate director of safety policy and communication, U.S. Food and Drug Administration Center for Drug Evaluation and Research


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