Arcoxia, the drug that Merck hopes will take the place of its withdrawn painkiller Vioxx, is getting mixed reviews from doctors, some of whom say that the results of studies on the drug do not make an adequate case for its approval.
Many have pointed out that Arcoxia was compared to an older drug (Voltaren) in clinical trials.
Both of the drugs raise the risk of heart problems, making Arcoxia's effects on the heart more difficult to assess. Even given that dubious comparison, more study patients quit taking Arcoxia due to elevated blood pressure, and congestive heart failure was more common among patients receiving higher doses of Arcoxia.
Dr. Steven Nissen, a cardiologist who formerly headed the FDA's cardiac drug advisory panel, believes that the drug should not be approved. Dr. David Graham, an FDA drug safety expert who has criticized his agency's handling of Vioxx, agreed with Nissen. Vioxx, like Arcoxia, is a kind of drug called a cox-2 inhibitor; Vioxx was pulled from the market in 2004 over safety concerns about heart risks.
In the wake of the controversy, Merck is now limiting its FDA request regarding the approval of Arcoxia to two dose levels for osteoarthritis, rather than for a range of doses and treatments, including for rheumatoid arthritis.