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A recent study has raised concerns about the safety of Merck's new painkilling drug, Arcoxia. The medical community is saying the drug poses risks similar to those of Vioxx.
Merck hoped that Arcoxia would replace Vioxx, their older painkiller, which was removed from the market in 2004 because it was linked to an increased risk of stroke and heart attack.
The new drug, belongs to the same class of drugs that Vioxx does: cox-2 inhibitors. The drug has not been approved by the FDA for sale in the United States, but it is already being sold in other countries.
The Study Findings
There were three studies performed by Merck on 34,000 arthritis sufferers from 38 countries, including the United States. The results were revealed at the American Heart Association conference.
The patients, one-third of which already had heart disease, and the rest of which had risk factors for it, were given either Arcoxia, or another painkiller, diclofenac. Diclofenac has already been linked with heart problems. The results showed that the two drugs gave similar results.
Of the 17,412 patients who were given Arcoxia, 320 had circulatory health issues involving blood clots. The rate for diclofenac was nearly identical. Of the 17,289 patients who took diclofenac, 323 of them suffered the same type of problems.
The study also found that about 2.5 percent of subjects in both study groups suffered a heart attack, stroke, or death within 4 years.
Flaws in the research?
Critics are saying that Merck's research was flawed, citing that they tested the drug against another drug known to have a negative impact on cardiovascular health, instead of testing it against a drug that is known to be heart-friendly.
“The development program for Arcoxia is fatally flawed. My advice to the FDA is that they should not approve this drug,” said former head of the FDA's cardiac advisory panel.
Another FDA safety expert, Dr. David Graham agreed. “It's my own suspicion that this study was intentionally designed to minimize the possibility of their having a repeat of what happened with VIGOR,” (the study that revealed the Vioxx risks) he said.
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