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Suprofen and the Flank Pain Syndrome

Allen C. Rossi, DDS, MS; Lynn Bosco, MD, MPH; Gerald A. Faich, MD, MPH; Ann Tanner, RPh; Robert Temple, MD

JAMA. 1988;259(8):1203-1204.

Abstract
The role of spontaneous reporting in detecting the suprofen-associated flank pain syndrome was examined, including the specific effect of the "Dear Doctor" letter in accelerating the information-gathering process once the initial signal was generated. We believe this to be a noteworthy example of the ability of spontaneous reporting to produce a timely and unequivocal signal of drugrelated risk. It also serves to demonstrate the need for vigilant postmarketing surveillance for all newly marketed drugs in the United States, even though considerable premarketing and postmarketing drug experience may exist from use in countries outside of the United States.

(JAMA 1988;259:1203-1024)

Author Affiliations
From the Office of Epidemiology and Biostatistics (Drs Rossi, Bosco, and Faich and Ms Tanner) and the Office of Drug Research and Review (Dr Temple), Center for Drugs and Biologics, Food and Drug Administration, Rockville, Md.

Footnotes
The opinions expressed herein are those of the authors and do not necessarily represent those of the Food and Drug Administration.

Reprint requests to the Division of Epidemiology and Surveillance (HFN-730), Center for Drugs and Biologics, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857 (Dr Rossi).

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