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Newly disclosed documents indicate a committee overseeing a key Vioxx® study found increased risks of various heart problems in patients after just four months, according to a published report.
At the time Merck pulled Vioxx® from the market last September, the drug maker said a fresh review of the same clinical trial data only found significant evidence of heart attacks or strokes after patients took the medication for 18 months.
However, the committee members expressed concern in meeting notes about the trend showing the possible effect of Vioxx® on heart attacks and stokes, according to the report. The first meeting took place in January 2002, nearly two years before Vioxx® was withdrawn.
Despite signs of heart problems, the report said the committee kept the trial going to determine whether Vioxx® would be useful in treating colon polyps.
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