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Doctors say Vioxx risks lingered a year after patients stopped use

May 13, 2006 | AP

People who took the painkiller Vioxx were at increased risk of heart attack and stroke for at least a year after they stopped taking the drug, several doctors said Friday, challenging claims the drug's maker had made a day earlier.

The physicians disputed the interpretation of a study by Merck & Co., Vioxx's maker.

Company officials had contended Thursday that Vioxx users weren't at increased risk of heart attack or stroke in the year after quitting the drug.

"Merck misrepresented the results of this study," said Dr. Steven Nissen, a cardiologist at the Cleveland Clinic who is leading a large international study of several painkillers and their risks.

Several other doctors agreed, although one said the risk appeared to decline somewhat during the one-year follow-up period.

Merck contends the number of patients in the affected group was so small the data were not "statistically significant," meaning that something other than Vioxx could have affected the patients' health.

But the doctors said that, depending on which way the data are calculated, patients who had taken Vioxx had a 64 percent to 85 percent higher risk of heart attack, stroke and death during the year after stopping the drug, compared with patients who were taking a placebo.

In addition, the Vioxx group on average had a 74 percent higher risk of cardiac complications throughout the three years they were on the drug and the one-year follow-up.

Merck spokesman Michael Heinley, asked about the doctors' claim that Merck's statements were misleading, said, "That would be their opinion."

During a teleconference with reporters and stock analysts late Thursday after Merck released the new data, Merck Research Laboratories President Peter S. Kim repeatedly stressed that there was no statistically significant increase in heart attack and stroke risk in the year after the study patients stopped taking Vioxx.

Merck pulled Vioxx from the market in 2004 because of data showing it doubled the risk of heart attack and stroke after 18 months' use.

The company faces about 10,000 lawsuits over the drug and has lost half of the six cases that have been tried so far.


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