The U.S. Food and Drug Administration last week turned down pharmaceutical giant, Merck & Co.’s request to market Arcoxia, a successor to its banned arthritis drug Vioxx, according to an article posted on HealthDay’s Web site. The decision came as little surprise, since an FDA advisory panel of medical experts had already voted 20-1 on April 12 against the approval of Arcoxia, a drug very similar to Vioxx.
Arcoxia (etoricoxib) is a cox-2 inhibitor, the same class of drugs that includes Vioxx, Bextra and Celebrex. Vioxx was withdrawn from the market in September 2004, after studies showed it doubled the risk for heart attack and stroke. Bextra was withdrawn for similar reasons early in 2005. Celebrex remains on drug store shelves, albeit with a strong warning label highlighting potential heart risk. Merck is still reeling under lawsuits filed by thousands of plaintiffs across the nation, several of whom are still awaiting their day in court.
The FDA decision was preceded by a barrage of criticism over Arcoxia’s potential risk for increasing heart attacks and strokes, particularly among people with existing heart disease. Arcoxia is designed to treat the pain of osteoarthritis without the harsh stomach effects associated with painkillers such as aspirin. But in his testimony before the agency’s advisory panel, FDA scientist Dr. David Graham said drug safety studies performed on Arcoxia were neither adequate nor reasonable to support its approval, the article said.
“What you’re talking about is a potential public health disaster” Graham said of Arcoxia. “We could have a replay of what we had with Vioxx.”
The fact that Merck faces more than 10,000 lawsuits related to Vioxx and is still pushing a drug that critics call “the offspring of Vioxx” is simply amazing. Their track record proves time and again that they like to put drugs in the market without proper testing. The FDA should be commended for disapproving this new drug, which if approved, could have caused a similar travesty as its predecessor, Vioxx. At Bisnar|Chase, we still have about 50 clients who are awaiting their trials on Vioxx cases.
For more information on heart disease and cox-2 inhibitors, visit the American Heart Association’s Web site, www.americanheart.org. If you have suffered the adverse effects of Vioxx or other defective drugs, call me for a free consultation.