Positive inotropic agent labeling should discuss risks of long-term use in CHF -- FDA advisory committee.
POSITIVE INOTROPIC AGENT LABELING SHOULD DISCUSS RISKS OF LONG- TERM CHF USE FDA's Cardiovascular & Renal Advisory Committee unanimously agreed at its Jan. 27 meeting. The committee voted 10-0 with one abstention that labeling of approved I.V. positive inotropic agents for congestive heart failure be revised along the lines of language proposed by FDA that "experience with intravenous in controlled trials does not extend beyond 48 hours of repeated boluses and/or continuous infusions. In a multicenter trial of oral , long-term use was associated with an increased risk of hospitalization and death, and patients with NYHA Class IV symptoms appeared to be at particular risk."
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