May 22, 2001 - Doubts Are Raised on the Safety of 2 Popular Arthritis DrugsAugust 10, 1998 - Self-Made King Of Viagra Suits?
There is a growing concern that Vioxx and Celebrex, two wildly popular arthritis drugs, are not as safe as they were initially believed to be. The two arthritis drugs remain the best-selling medicines in the world.
The companies that manufacture these two drugs spend a lot on advertising and claim that they cause fewer ulcers than many other pain relievers. Both Pharmacia, producer of Celebrex, and Merck, the maker Vioxx, are heavily dependent on the drugs for their sales growth and profit.
Celebrex is Pharmacia's biggest-selling drug that generates sales of $2.3 billion a year. Pfizer co-markets Celebrex with Pharmacia. Vioxx is Merck's second biggest drug , after the cholesterol medicine Zocor, bringing the company a revenue of $1.7 billion a year.
While the data is still limited, a large study sponsored by Merck last year showed that patients taking Vioxx had four times the risk of heart attacks of patients taking another pain reliever, Naproxen, which is sold both generically and under the brand names Naprosyn or Aleve.
The current debate centers on whether the higher heart attack rate found in patients taking Vioxx is a result of the drug's actually causing damage in some patients or to an absence of the heart-protecting benefits that naproxen may have.
According to researchers for the Food and Drug Administration, patients taking Vioxx, a Merck & Company drug, had a higher, but still relatively low, risk of heart attacks than patients taking an older pain reliever. The study received little public attention at the time, but the FDA is considering whether to add information on possible cardiovascular side effects to both drugs' labels.
Merck officials said the research does not show a problem with Vioxx. Instead, the company believed naproxen acted to reduce heart attacks by working much like aspirin. Information from Merck's study was presented to the FDA in February when the companies asked for changes on their drug labels to reflect data showing that Vioxx and Celebrex caused fewer ulcers than other pain relievers.
Richard R. Stover, a pharmaceutical industry analyst at Arnhold & S. Bleichroeder Inc., did his own analysis of what he called "disturbing data" from Merck's study. In an interview, Mr. Stover said he was warning his clients, many of whom were institutional investors who hold Merck shares, that they should watch the issue carefully since it could hurt the company's stock price.
However, some doctors are worried about both drugs. Dr. M. Michael Wolfe, chief of the gastroenterology section at the Boston University School of Medicine and a member of the F.D.A. advisory committee said that "There must be a warning because the marketing of these drugs is unbelievable," and said that he is "sure there are many people out there who are taking these drugs that should not be."
Other physicians say they are also worried about the possibility of heart attacks because many of the arthritis patients taking the drugs are elderly and have a higher risk of cardiovascular problems to begin with.
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