FDA Approves New Indication and Label Changes for Popular Arthritis Drug

Rofecoxib (trade name: Vioxx), approved for treatment of osteoarthritis and pain, has won a supplemental indication for rheumatoid arthritis, the FDA announced. Further, the label will be modified to warn patients and health care professionals about certain gastrointestinal risks, and against chronic use of the medicine at a specific dosage. The geriatric section of the label will also be modified, the FDA notes.