April 12, 2007
Drug May Raise Risk Of Stroke, Heart Attack, Scientist Says
WASHINGTON -- A federal drug safety expert is raising red flags about a painkiller proposed as a successor to Vioxx.
Food and Drug Administration scientist Dr. David Graham said the new drug, called Arcoxia, may substantially increase the risk of stroke and heart attack.
He also said it does not provide any more pain relief than other drugs in its class.
Graham has told an advisory panel the drug could lead to a "potential public health disaster" and a "replay" of what happened with Vioxx.
The Merck company withdrew Vioxx in 2004 because it was linked to an increased risk of stroke and heart attack. The company said it has "comprehensively characterized the safety and efficacy profile" of Arcoxia.
However, Graham said safety studies on the proposed drug are not adequate or reasonable enough to support its approval.