FDA reviewed a meta-analysis of randomized clinical trials of cardiovascular and upper gastrointestinal events with non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs), conducted by the Coxib and traditional NSAID Trialists’ (CNT) Collaboration of the Clinical Trial Service and Epidemiological Studies Units at Oxford University. 2 We also reviewed observational studies and other scientific publications in the medical literature. 1 The findings of these studies were discussed at a joint meeting of the Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee held on February 10-11, 2014 (for complete safety reviews, background information, and minutes of this meeting, click here ).
SOURCES: Byron Cryer, MD, spokesman, American Gastroenterological Association; associate professor of medicine, University of Texas Southwestern Medical Center, Dallas. Nieca Goldberg, MD, spokeswoman for the American Heart Association; chief of women's cardiac care, Lennox Hill Hospital, New York; author, Women Are Not Small Men: Lifesaving Strategies For Preventing And Healing Heart Disease In Women . John Klippel, MD, president and CEO, Arthritis Foundation, Atlanta. Scott Zashin, clinical assistant professor, University of Texas Southwestern Medical Center; author of Arthritis Without Pain . American College of Rheumatology web site. Arthritis Foundation web site. American Heart Association web site. American College of Gastroenterology web site. American Gastroenterological Association web site. American Academy of Family Physicians web site. American Academy of Allergy, Asthma, and Immunology web site.