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An advisory panel of federal drug regulators rejected Merck & Co.'s application to sell its newest painkiller Arcoxia, citing serious concerns that the drug is linked to cardiovascular events including heart attacks and strokes.
Arcoxia is Vioxx's sister drug—also manufactured by Merck—which was pulled from the U.S. market in 2004 after studies found the drug heightened patient's risk of suffering heart attacks, strokes, and death.
Currently, Arcoxia—a Cox-2 inhibitor—is distributed in 63 countries worldwide, and extensive clinical studies have been conducted to determine the safety and efficacy of the drug.
Heart Risks
Clinical tests, involving 34,000 arthritis patients, have found that Arcoxia is likely to cause about three times as many heart risks and deaths as over-the-counter pain medication Aleve, but is no more effective in managing pain. Furthermore, Arcoxia patients experienced concerning increases in blood pressure.
“What you're talking about is a potential public health disaster” if the drug is approved, said Food and Drug Administration safety advisor Dr. David Graham.
“There is nothing special about this drug that would warrant giving it to patients and putting them at risk of cardiovascular death,” added Dr. David Felson, a panel member.
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