Food and Drug Administration

Nonprescription Drugs Advisory Committee

September 20, 2002

Slides

Presentation on OTC Drug Products, Dr. Charles Ganley, MD, FDA  htm  ppt

Overview of Aspirin and NSAID's Label Warnings, Dr. William Gilbertson, PharmD., FDA  htm   ppt

OTC NSAID and ASA GI Bleeding Analysis of Spontaneous Reports, Dr. Joyce Weaver, PharmD., FDA  htm   ppt

Risks of NSAIDS: Focus on GI Risks of OTC NSAIDs, Dr. Byron Cryer, MD, U. of Texas Southwestern Medical School   htm   ppt

OTC NSAIDs and Nephrotoxicity, Dr. Juan Pelayo, MD, FDA   htm  ppt

NSAIDs and GI and Renal Complications, Lessons from Tennessee Medicaid Population Studies (and selected others)   htm   ppt

Epidemiology of Aspirin and Other NSAIDs, Dr. Kenneth Rothman, DrPH, Boston University  htm  ppt

Presentations by Dr. Roger Berlin, MD, et. al., Global Scientific Affairs Wyeth  htm   ppt

Presentation on Bayer OTC Analgesic Products, Dr. Allen Heller, MD, Bayer Corp. Consumer Care Division   htm   ppt

Risk of GI Bleed on NSAIDs, Prof. Michael Langman, U. of Birmingham, UK   htm   ppt

Ibuprofen and Renal Failure, Prof. Nicholas Moore, U. of Bordeaux, France  htm   ppt

Open Public Hearing

Acetaminophen Overdoses: A Review of Intentional and Unintentional Cases, Dr. Sarah Erush, PharmD, BCPS and Dr. Karen Shalaby, PharmD, Hospital of the U. of Pennsylvania  htm   ppt