NONPRESCRIPTION DRUGS ADVISORY COMMITTEE

October 19, 2000

Safety Issues of Phenylpropanolamine (PPA) in Over-the-Counter Drug Products

OPEN PUBLIC HEARING

Brian Strom, M.D., MPH, University of Pennsylvania representing Whitehall Corporation ppt htm

Statement on Phenylpropanolomine, David E. Schteingart, M.D., University of Michigan representing Chattem doc pdf

Statement of Sidney Wolfe, M.D., Director, Public Citizenís Health Research Group doc pdf

FDA PRESENTATIONS

Regulatory History of OTC Phenylpropanolamine Hydrochloride, Robert L. Sherman, DOTCDP ppt htm

Epidemiological Consult on the Yale Study and Recommendations to OTC Division, Lois La Grenade, M.D., M.P.H., Office of Postmarketing Drug Risk Assessment ppt htm

Summary of Issues, Charles Ganley, M.D., Director, DOTCDP ppt htm

YALE

Final Report of the Yale Hemorrhagic Stroke Project, Walter Kernan, M.D., School of Medicine, Yale pdf

COMMENTS ON THE YALE STUDY BY THE CONSUMER HEALTHCARE PRODUCTS ASSOCIATION

R. William Soller, Ph.D., Senior Vice President and Director of Science and Technology CHPA ppt htm

Noel S. Weiss, M.D., Dr. P.H., University of Washington pdf

PPA and the Risk of Hemorrhagic Stroke, Lewis H Kuller, MD DrPH, MPH, University of
 Pittsburgh School of Health  pdf

Robert B Wallace, MD, University of Iowa College of Public Health and Medicine pdf

Philip B Gorelick MD MPH FACP, Rush Medical College pdf