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BMJ 2005;331:293-294 (30 July), doi:10.1136/bmj.331.7511.293-a
| The first 150 words of the full text of this article appear below. |
EDITORVidal et al should be congratulated on the first scholarly, systematic review of secondary sources of prescribing information for patients with impaired renal function (p 263).1 That they found inconsistent and conflicting recommendations across multiple sources is not surprising. Their work underscores several problems with which we have struggled to compile our dosing recommendations in Drug Prescribing in Renal Failure.2
Early regulatory requirements did not include formal efficacy, safety, or pharmacokinetic studies for drugs in special populations, including patients with impaired kidney or liver function. Consequently, dosing recommendations for many older drugs are based on flimsy data, including sparse case reports, common usage, and pharmacokinetic extrapolations from studies in subjects with normal renal function. in patients with impaired renal function, but the reports are often absent from the critically reviewed, scientific literature. The results are buried in regulatory reports or found only in other secondary
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George R Aronoff, professor of medicine and pharmacology
University of Louisville Kidney Disease Program, 615 South Preston Street, Louisville, KY 40202, USA George.Aronoff@kdp.louisville.edu