April 10, 2007
Heart experts say Arcoxia too risky for approval and use
A pair of prominent heart experts said in a published report Thursday that studies of Merck’s COX-2 selective inhibitor Arcoxia revealed risks that make it unacceptable for approval in the US and that the drug poses unacceptable dangers to patients in countries where it is already sold.
The concerns were expressed in an interview with Reuters by Dr. Steven Nissen, head of cardiology at the Cleveland Clinic and Dr. Curt Furberg, a professor of public health at Wake Forest University who is a member of the Drug Safety and Risk Management Advisory Committee of the FDA.
Nissen and Furberg said patients taking Arcoxia in a large international trial had a higher incidence of edema, elevated blood pressure and congestive heart failure than patients taking the standard treatment, diclofenac.
Nissen said, “This is a genie I don’t want to see let out of the bottle,” predicting the FDA will refuse to approve Arcoxia.
Furberg added that “all versions of Arcoxia should be taken off the market now,” referring to the 63 nations where Arcoxia is currently approved for use.
Merck spokesman Chris Loder told Reuters he disagreed with Nissen’s and Furberg’s assessment of Arcoxia.
“The product has been evaluated and re-evaluated by regulators in 63 countries, including the European Union,” Loder said. He added that regulators continue to believe the drug’s benefits outweigh its risks.
Merck is currently awaiting FDA approval of Arcoxia, which works through the same mechanism as Vioxx.
Arcoxia had global sales of $265 million last year.