Merck has released data indicating that Arcoxia performed better than the generic diclofenac in treating arthritis. The data suggests that Arcoxia was no more dangerous than the older drug diclofenac in raising the risk of a heart attack and the drug had fewer side effects, although more patients taking Arcoxia dropped out of the study due to high blood pressure or swelling tissues. But several drug safety experts harshly criticized the company's decision to compare Arcoxia, which Merck has long hoped would be a successor to Vioxx, to diclofenac, which is known to raise the risk of heart attacks and strokes. Prominent cardiologist Dr. Steve Nissen (photo) of the Cleveland Clinic said that the FDA should not approve Arcoxia with this type of data.
ALSO: Merck has decided to revise its application for FDA approval of the closely-watched Arcoxia, according to a report in The Wall Street Journal. The drug giant now plans to seek approval only for osteoarthritis, dropping rheumatoid arthritis and other indications. Report
PLUS: The new CEO at Merck, Richard Clark (photo), has been earning kudos from Wall Street after a string of new drug approvals and better bottom-line results, but the jury is still out on whether he can navigate the pharma giant around the upcoming loss of patent protection on some of its biggest blockbusters. Article (WSJ sub. req.)
FDA whistle-blower attacks safety of Arcoxia. Report
Merck presents Arcoxia data. Report
Nissen named to Cleveland Clinic post. Report