14 DAY TRIAL // Former users of Merck & Co's Vioxx arthritis drug could be at risk of developing strokes for years, a prominent public health expert said on Thursday after examining new data from the drug manufacturer.
"It may be that Vioxx is causing permanent damage to the cardiovascular system, accelerating atherosclerosis or a sustained increase in blood pressure," said Dr. Curt Furberg, a member of the U.S. Food and Drug Administration's Drug Safety and Risk Management Advisory Committee.
Furberg, a professor of public health at Wake Forest University, said his stroke concerns stem from a new 107-page report on patients who were followed for a year after they stopped taking Vioxx. The drug, used by 20 million Americans, was recalled in late 2004, after it was shown to double heart attack risk among patients taking it 18 months or longer.
Merck issued a news release last week that briefly described the lengthy report, and made the report available for Reuters. It said 28 people from the 3-year trial had heart attacks and strokes a year after they stopped taking Vioxx, compared with 16 patients from the trial that had taken placebos. The difference, however, was not deemed statistically significant.
Furberg said his examination of the full report shows 7 Vioxx users had strokes, while two Vioxx users had mini-strokes in the year-long follow-up period - compared with no such incidents in the placebo group.
"These data raise some very important questions because for a while we assumed Vioxx caused temporary problems, and here it is more than that. It could be causing permanent damage," Furberg said in an interview. "In the past we weren't quite sure of the stroke risk, so stroke is now back on the agenda in a bigger way."
Merck spokesman Michael Heinley said the stroke risk from Vioxx had not been seen in earlier trials of the drug, including a long-term trial of Vioxx to prevent Alzheimer's disease. "We've consistently seen no increased risk of stroke in people taking Vioxx," Heinley said.
He said the risk for stroke would not have been statistically significant in the follow-up of patients in the latest APPROV e trial, if data for several placebo patients who developed strokes had become available before the cut-off date for the review. Even so, strokes were four times more widespread among those who took Vioxx, than those who took placebos.