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24.2.12

Vioxx Under Scrutiny

Vioxx Under Scrutiny
Vioxx may increase patients risk of heart attack, stroke and kidney failure according to a studies that have appeared in Medical Journals.
A class of drugs called COX-2 inhibitors was developed in the late 1990's, COX-2 inhibitors were generally promoted as being safer and better pain treatment than the traditional and widely used nonsteroidal anti-inflammatory drugs, known as NSAIDs, examples being aspirin and ibuprofen.

However, studies have led some researchers to questions the cardiovascular safety of Vioxx and other COX-2 inhibitors such as Celebrex.Another study published in the Medical Journal, The Lancet indicated that this group of drugs may harm the kidneys. In the article, two Spanish doctors, describe the case of a 67-year-old woman who developed kidney failure. Her kidney failure ended after she stopped taking Vioxx, leading the doctors to conclude that the kidney problems she experienced were related to the ingestion of the drug. This was the first case to show that COX-2 inhibitors may be associated with Kidney problems. It was not the Last.
Kidney Failure?

Both Merck, the manufacturer of Vioxx, has since reported several instances kidney failure possibly associated with their drug, and Pharmacia, the manufacturer of Celebrex another popular COX-2 , has received similar reports in people taking their drug. As of this writing, none of the reported conditions were conclusively diagnosed as kidney failure directly related to the drugs.
Kidney problems are a side effect of all NSAIDs including COX-2 inhibitors, according to researchers in the field. Therefore the mounting evidence suggesting an association between kidney failure and COX-2 inhibitors is not surprising. The companies are apparently aware of this and the current labels for Vioxx carry the same warnings and risks as NSAIDs, including the potential for kidney damage.
Some doctors believe that Vioxx and COX-2 drugs are no more effective than other NSAIDs. They also conclude with the mounting evidence that there is no safety advantage.
They argue that patients suffering from conditions such as arthritis patients should taking an NSAID, such as ibuprofen. Merck promotes VIOXX, which is much more expensive, while the patient would be better off financially and medically taking a cheaper drug, one which is a fraction of the price of Vioxx.




Heart Attack Risks
In addition to kidney failure, researchers are concerned about the increased the risk of heart attacks. In February, the FDA's arthritis drugs advisory committee analyzed COX-2 inhibitors cardiovascular risks. Merck presented a study to support its contention that Vioxx is safer on the gastrointestinal tract than other NSAIDs. Although the study found that Vioxx reduced the incidence of ulcers and other gastrointestinal problems by about half that of the over-the-counter NSAID Aleve, the study showed that people taking Vioxx had four times the risk of a heart attack.
However, Merck claims their Vioxx studies show no evidence that the drug increases the risk of a heart attack compared with other NSAIDs. The company claims that Vioxx has little effect on the heart. They claim that the study appeared to increase the risk of a heart attack because Aleve the drug in the study, like aspirin, actually reduces heart attack relative to people on Vioxx.
The FDA is considering changing the label of Vioxx to highlight the potential for heart problems.
In February an FDA panel concluded Vioxx should retain its strong warning that it can cause ulcers like the older, less expensive painkillers - the panel also concluded that doctors and patients should be warned that it might carry a heart attack risk. The panel said patients and doctors must be warned that in the study, Vioxx patients had more than twice the risk of heart attacks or other cardiovascular side effects as traditional pain killers users.
FDA's advisers concluded that more research is needed but that Vioxx's label should warn of the concern and potential danger. Although the FDA isn't bound by its advisers' recommendations it usually follows them.




FDA Says Merck Misleads on Vioxx Safety
September 2001

The government has ordered Merck & Co. to cease promotions aimed to get doctors to prescribe its blockbuster arthritis painkiller Vioxx, saying they minimize potential safety risks.
The Food and Drug Administration told Merck to set the record straight by sending a ``Dear Doctor'' letter to all health workers who may have been exposed to the misleading campaign.
The main issue: Whether Vioxx users face an increased risk of heart attacks and strokes. A recent study comparing Vioxx to another painkiller, naproxen, suggested they do. Many heart experts are divided about the risk and want more research. But an FDA advisory panel has said Vioxx should carry a warning label about the potential risk.
Merck has argued that Vioxx falsely looked risky because naproxen thins the blood much like aspirin does and thus protected against heart attacks. It aired that view in the recent promotions that state,

``Vioxx is a wonderful, effective'' painkiller but not one that has a blood-thinning side benefit.
``In fact, the situation is not at all clear,'' the FDA responded, saying no studies prove naproxen thins blood enough to explain the discrepancy.
``The company continues to stand behind the overall safety and cardiovascular safety of Vioxx,'' said Merck spokeswoman Jan Weiner.

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