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Report problem labels to manufacturer, safety officials

Pharmacy Regulation Resource, May 4, 2005

The recent name change of an Alzheimer's disease drug because of cases in which it was confused for a similar-sounding drug highlights the importance of reporting errors and potentially dangerous drug names to manufacturers and the proper authorities, experts say.

Ortho-McNeil Neurologics Inc. on April 11 announced that it was changing the name Reminyl to Razadyne to eliminate confusion with the Sanofi-Aventis drug Amaryl, which treats diabetes mellitus. According to reports submitted to the FDA and U.S. Pharmacopeia (USP), some prescriptions were incorrectly written, interpreted, labeled or filled, resulting in two deaths.

"It underscores the importance of reporting these kinds of things," says Diane Cousins, RPh, vice president of the USP Center for the Advancement of Patient Safety in Rockville, MD.

Pharmacists that notice potential errors that could occur from medication labeling or drug names should report the problem to the drug's manufacturer, the FDA, and USP, Cousins says.

Razadyne will be available to pharmacies beginning in July, according to an Ortho-McNeil press release.

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