Vioxx (rofecoxib) - May 6, 2002
Audience: Healthcare professionals treating patients with osteoarthritis, rheumatoid arthritis, acute pain, and primary dysmenorrheaFDA and Merck strengthened the WARNINGS, PRECAUTIONS, and CLINICAL STUDIES sections of Vioxx labeling to describe new cardiovascular and gastroenterological safety information. This information reflected the results of a prospective, active control study of Vioxx 50 mg daily versus naproxen 500 mg twice daily and from a placebo-controlled trials database. This information should be taken into consideration and caution should be exercised when Vioxx is used in patients with a medical history of ischemic heart disease.
[April 11, 2002 Talk Paper - FDA]
[April, 2002 Letter - Merck] 48 KB PDF file
[April, 2002 Full, revised, highlighted label - Merck] 2.4 MB PDF file
[April, 2002 Patient Package Insert, highlighted - Merck] 31 KB PDF file