Arcoxia, the drug that Merck hopes will take the place of its withdrawn painkiller Vioxx, is getting mixed reviews from doctors, some of whom say that the results of studies on the drug do not make an adequate case for its approval.
Many have pointed out that Arcoxia was compared to an older drug (Voltaren) in clinical trials.
Both of the drugs raise the risk of heart problems, making Arcoxia's effects on the heart more difficult to assess. Even given that dubious comparison, more study patients quit taking Arcoxia due to elevated blood pressure, and congestive heart failure was more common among patients receiving higher doses of Arcoxia.
Dr. Steven Nissen, a cardiologist who formerly headed the FDA's cardiac drug advisory panel, believes that the drug should not be approved. Dr. David Graham, an FDA drug safety expert who has criticized his agency's handling of Vioxx, agreed with Nissen. Vioxx, like Arcoxia, is a kind of drug called a cox-2 inhibitor; Vioxx was pulled from the market in 2004 over safety concerns about heart risks.
In the wake of the controversy, Merck is now limiting its FDA request regarding the approval of Arcoxia to two dose levels for osteoarthritis, rather than for a range of doses and treatments, including for rheumatoid arthritis.
Looks like my hero at the FDA, Dr. David Graham (the physician who exposed the Vioxx scandal to Congress), is on track again.
He strongly believes that the study used to approve this drug was intentionally designed to minimize the possibility of their having a repeat of what happened with the VIGOR study, which revealed Vioxx's heart risks.
Dr. Graham said that the new research "raises red flags," and the drug should never have been approved. He said, "There's every reason to think it suffers from the same problems as Vioxx."
I was the first person to warn the public about Vioxx five years before it was taken off the market. So PLEASE don't let them deceive you again. If your doctor even suggests using the new drug Arcoxia (etoricoxib), Merck's newest replacement for its heart-stopping pain reliever Vioxx, run as fast as you can in the other direction.
Unless, that is, you want to risk following the path of the 60,000 that met an early death by taking Vioxx.
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Fortunately there are several natural and protective ways to treat your pain without resorting to a potentially toxic drug like Arcoxia, including: