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From the Food and Drug Administration
October 7, 1998

Questions Raised Regarding Benefit of Albumin or PPF for Seriously Ill Patients

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JAMA. 1998;280(13):1128. doi:10.1001/jama.280.13.1128-JFD80009-4-1

The FDA has issued a letter to alert physicians to recent literature reports that question the medical benefit of administration of albumin or plasma protein fraction (PPF) to seriously ill patients (http://www.fda.gov/medwatch/safety/1998/plasma.htm). One meta-analysis showed an excess mortality for combined groups of patients with hypovolemia, burns, or hypoproteinemia who received albumin instead of, or in addition, to crystalloid solutions. Until results from further, well-focused studies are available, the FDA urges physicians to exercise discretion in the use of albumin and PPF based on their own assessment of these reports.

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