News Briefs
Delay nursing home stay
Treatment with Eisai/Pfizer’s donepezil (Aricept) may delay dementia-related nursing home placement for Alzheimer’s patients by nearly two years, according to results of a retrospective study recently presented at the 14th meeting of the American Association of Geriatric Psychiatry. The researchers analyzed data from three clinical trials involving 671 patients and found that patients taking at least 5 mg of donepezil a day for at least nine to 12 months had a 21-month delay in nursing home placement compared with patients receiving limited donepezil treatment or placebo.
Delaying nursing home placement may lessen the emotional and financial burdens associated with caring for Alzheimer’s disease patients, the companies say. This is the third study to suggest that donepezil may offer cost-effectiveness advantages and reduce the burden of caregiving. Eisai/Pfizer conducted the studies in the hope that the findings would provide economic incentives for U.S. managed care organizations to use their product in Alzheimer’s patients.
(Editor’s note: For more information about Alzheimer’s disease treatment, see Drug Criteria and Outcomes in this issue.)
FDA issues public health advisory
The FDA has issued a public health advisory concerning itraconazole (Sporanox) and terbinafine hydrochloride (Lamisil) systemic drug therapies to treat onychomycosis (fungal nail infections).
Health care providers are notified of the possible association of serious cardiac and hepatic adverse events with the administration of these products. New labeling for both drug products recommends that health care providers confirm the diagnosis by testing nail specimens prior to prescribing the medications. The FDA’s concerns do not apply to the over-the-counter versions of terbinafine, which are topical creams.
For additional information, including links to the FDA Talk Paper, FDA Public Health Advisory, FDA Q’s and A’s, and the revised Sporanox and Lamisil labels, visit the MedWatch Safety Summary entry for Sporanox and Lamisil at www.fda.gov/medwatch/safety/2001/safety01.htm#sporan.
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