Short-Term Vioxx® Use May Be Harmful, Correction to Journal Article Says
BOSTON, MA -- June 30, 2006 -- The painkiller Vioxx® (rofecoxib) can increase patients' risk for heart attacks or strokes, even if they take the drug for less than 18 months. The New England Journal of Medicine came to this conclusion when it found mathematical and statistical errors in a previously published article that used data from Merck, the manufacturer of Vioxx®.
The Journal corrected the analysis of a three-year clinical trial in which Vioxx® was prescribed to treat patients with colon polyps (the APPROVe report). That study found that Vioxx® users had an increased risk of heart attacks and strokes compared with those who took placebos (sugar pills). Merck had pointed to figures from the APPROVe study to indicate that a patient must take Vioxx® for 18 months before heart problems can occur. The Journal has now deleted this 18-month date as insignificant.
Last month, Merck provided the results of a one-year follow-up of APPROVe participants. Its report to the Food and Drug Administration (FDA) includes a graph that indicates heart problems beginning at three or four months after Vioxx® use (Wall Street Journal, May 18, 2006). The original report had followed patients for only two weeks after they took Vioxx®.
In its heyday, Vioxx® was a blockbuster drug for Merck, bringing in about $2.5 billion per year. Merck pulled Vioxx off the market in September, 2004, when the drug's heart attack and stroke risks became public information. According to some estimates, Merck now faces more than 11,500 lawsuits by Vioxx® users. Many attorneys feel that the corrections made by the New England Journal bolster the cases of injured Vioxx® users who took the drug for only a short time.