FDA implements new geriatric labeling
FDA implements new geriatric labeling
New "geriatric use" indications on prescription drug labels will be mandatory by 2003 under a final ruling by the U.S. Food and Drug Adminis-tration. The labeling emphasis is on classes of drugs commonly used by seniors, including anticoagulants, calcium channel blockers, digoxin, and anti-arrhythmics, focusing on drug and disease interactions, therapeutic ranges, and adverse reactions. While no additional clinical studies will be mandated for that labeled information, the FDA will rely on controlled studies that already are part of marketing applications and related literature for the geriatric use subsection of the new labels. The labeling will focus on a given drug’s effect on elderly patients and will include recommendations on the limits, hazards, or monitoring those patients should be aware of. t
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