C L I N . R E S . P R A C T I C E S & DRUG REG. A F F A I R S , 3 ( 4 ) , 417-418 ( 1 9 8 5 )

PROBLEMS OF INVESTIGATIONAL NEW DRUGS: SPECIAL PROBLEMS FOR THE INVESTIGATOR

Jacques R. Caldwell, M.D. Clinical Associate Professor of Medicine

University of Florida College of Medicine

100 Professional Boulevard Daytona Beach, Florida 32014

Two patients in experimental trials developed hematuria. One was subsequently diagnosed as having urinary bladder cancer and threatened a malpractice suit against the investigator and sponsoring company. spontaneously with no catise being determined. completed the drug protocol but later, long-term, animal data suggested that the experimental drug could cause urinary bladder cancer in rats.

The second patient's hematuria disappeared This patient

Based on these two patients, an algorithm fo r evaluation of hematuria in patients on drug studies has been developed. Causes of hematuria may be benign conditions such as prostati- tis, cystitis or urethritis, or may be more serious such as tumor, renal stone, tuberculosis or hemoglobinopathy. Workup may include IVP, cystoscopy and, rarely, renal arteriography or renal biopsy.

Drug-induced hematuria is rare. Most commonly it occurs in patients receiving anticoagulants or cyclosphasphamide.

The discussion will focus on three aspects: ( 1 ) Indica- tions for extensive hernaturia evaluation; ( 2 ) Approaches to the patient who threatens a malpractice suit fo r an incident

Copyright 0 1985 by Marcel Dekker, Inc.

417

0735-79 1.5/85/0304-0417$3.50/0

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418 SPEAKERS PRESENTATIONS FALL MEETING

that may or may not be related to an experimental d r u g , and

( 3 ) Approaches to the patient who received an investigational drug which was subsequently shown to be potentially carcino- genic.

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