Is this prescription for the treatment of Alzheimer's disease or insomnia?

April 3, 2006

The Food & Drug Administration would like to alert healthcare practitioners to three cases of medication dispensing errors in which the Alzheimer's medication Razadyne (galantamine, Janssen Pharmaceutica) was dispensed instead of the insomnia agent Rozerem (ramelteon, Takeda Pharmaceuticals) to geriatric patients. In two cases the wrong drug was actually administered to the patient but with no reported adverse outcomes, while the third error was caught prior to patient administration. Errors between these products could result in unnecessary adverse events or lack of efficacy.

Shortly following the approval of Razadyne as the name replacement for Reminyl, Rozerem entered the marketplace. The errors between this name pair have been linked to poor prescriber handwriting and misspelling of the drug name. Moreover, the products share an overlapping strength of 8 mg, and, when scripted, the first four letters of each name have a similar appearance. There is an overlapping dosing interval of once daily but only with the Razadyne ER product. Additionally, the name change to Razadyne was subjected to a large amount of publicity, which might provide more name recognition for Razadyne compared with Rozerem.

If you become aware of prescription dispensing errors involving Razadyne and Rozerem, please report these errors to the FDA MedWatch program by Internet at http://www.fda.gov/medwatch/.

CAROL HOLQUIST is Director of the Division of Medication Errors and Technical Support, Office of Drug Safety, at the Food & Drug Administration.