Creeping concern about COX-2 drugs; Ranking vaccine projects

Adverse events reported with the first approved COX-2 inhibitor last week failed to garner special attention of an FDA panel convened to review a second version of the molecule. But the agency and its advisors are raising concerns about potential difficulties created by dosing that routinely exceeds that prescribed by the label.

G.D. Searle & Co. launched its Celebrex celecoxib COX-2 inhibitor in the U.S. in mid-February to treat the pain and inflammation of rheumatoid arthritis (RA) and osteoarthritis. Sales in the quarter reached $279 million. But Searle's first quarter adverse event report included 10 deaths and 11 gastrointestinal (GI) hemorrhages for patients taking the specific COX-2 inhibitor...