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Drug Labels Successful Only if Public Can Find and Comprehend Warnings

Food and Drug Administration proposal to place stronger warning labels on certain over-the-counter medications is welcome news, says Ruth Day

Tuesday's Food and Drug Administration proposal to place stronger warning labels on certain over-the-counter medications is welcome news, but will be successful only if the public can locate the warnings and comprehend them, said a Duke University professor.

Ruth Day does research on how both patients and professionals understand, remember and use medical information in everyday life. She is a charter member of the FDA Advisory Committee on Drug Safety and Risk Management and continues as an FDA consultant.

"Information providers must present the warnings in a cognitively accessible way," said Day, who directs Duke's Medical Cognition Laboratory. "People must be able to find, understand, remember and use the information. Otherwise, the information may be present on the labels, but functionally absent for the users.

"Most people believe that drugs sold over the counter are entirely safe. However there are no ‘safe drugs' -- only ‘safe use' of drugs," Day said. "It is important to read label warnings on every purchase because new information may be given. And then read the label again."

She also urges consumers to learn and remember usage instructions, and monitor for possible side effects.