Vioxx News
Merck's Vioxx Tied to New Threat;
Heart Risks Start Early in Study
-WSJ
09/13/2006 - A study identified kidney-related risks for Merck & Co.'s withdrawn Vioxx painkiller, while another study said the drug's cardiovascular risks began soon after treatment, contradicting the company's claim that the risk increased only after long-term use.
One of these studies also found increased cardiovascular risks for an older painkiller, diclofenac, and suggests the drug's regulatory status should be reviewed. Diclofenac is marketed by Swiss drug company Novartis AG under the brands Cataflam and Voltaren.
Both studies were analyses of previous clinical trials, and were published online yesterday by the Journal of the American Medical Association.
Merck, based in Whitehouse Station, N.J., is in the midst of defending itself against thousands of lawsuits claiming that Vioxx use caused heart attacks and other injuries. Merck withdrew Vioxx from the market in September 2004.
Researchers at Harvard Medical School and Harvard's public-health school, who analyzed the results of 114 clinical trials in which some 116,094 people participated, concluded that Vioxx was associated with increased kidney and arrhythmia risks.
The finding of an arrhythmia risk was significant because the first Vioxx trial last year, which Merck lost, involved a man who took Vioxx and died of arrhythmia. Merck had argued during the trial that Vioxx wasn't linked to arrhythmias.
Merck said the Harvard researchers' analysis "addressed the known renovascular risk associated" with so-called Cox-2 inhibitors. It said that Vioxx's product label included information about the risk of peripheral edema and hypertension in certain people and that those risks were well documented in older pain drugs.
A study by researchers at the University of Newcastle in Australia said elevated cardiovascular risks associated with Vioxx could be observed during the first 30 days of treatment. Merck said previously reported data from clinical trials don't support interpretations that there is an increased cardiovascular thrombotic risk with short-term use of Vioxx.
Regarding the diclofenac findings, Novartis spokesman John Gilardi said: "Our view is that this meta-analysis is incomplete. Other epidemiological data does not indicate an increased cardiovascular risk of diclofenac" compared with other nonsteroidal anti-inflammatory drugs.
