Food and Drug Administration

Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee

February 17, 2005


Interpreting Observational Studies of Cardiovascular Risk of NSAIDs, Dr. Richard Platt, MD, MS, FDA (HTM) (PPT)

Review of Epidemiologic Studies on Cardiovascular Risk With Selected NSAIDs, Ddr. David Graham, MD, MPH, FDA (HTM) (PPT)

Analysis of Cardiovascular Thromboembolic Events With Etoricoxib, Dr. Joel Schiffenbauer, MD, FDA (HTM) (PPT)

Lumiracoxib Cardiovascular Safety, Dr. Lourdes Villalba, MD, FDA (HTM) (PPT)

Open Public Hearing


The statements contained in this document(s) are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.

Open Public Hearing Speakers (HTM) (PPT)

Presentation by Dr. Johnson (HTM) (PPT)

Presentation by Dr. Jennifer Lo, PhD, BioJENC, LLC (HTM) (PPT)

The Problem - How to Identify Safe and Effective Drugs for Humans, Dr. Pippen (HTM) (PPT)

The Wrong Scientific Evidence: Why Did Doctors Prescribe So Much Vioxx?, Dr. John Abramson, MD, Harvard Medical School (HTM) (PPT)

Chronic NSAID Use: Small Bowel Injury, Dr. Waqar Qureshi, MD, FACP, FAGG, Baylor College of Medicine (HTM) (PPT)

Molecular Basis for Increased Cardivascular Risk With Rofecoxib - A Comparative Analysis, Ddr. R. Mason, PhD, Harvard Medical School (HTM) (PPT)

Comparison of Therapeutic Concentrations of COX Inhibitors with Those Inhibiting by 80% COX-1 and -2 Activities in Whole Blood In Vitro, Dr. Patrignani (HTM) (PPT)

Small Bowel Toxicity of Nonselective NSAIDs Revealed by Capsule Endoscopy: Results From a Pivotal Clinical Trial, Dr. Glenn Eisen, MD, MPH, Oregon Health and Science University (HTM) (PPT)

Safety of Nonsteroidal Anti-Inflammatory Drugs (NSAID) - An Over-the-Counter (OTC) Perspective, Dr. Linda Suydam, DPA, Consumer Healthcare Products Assoc. (HTM) (PPT)