Vioxx, which was used by millions of Americans, was recalled worldwide in September, 2004 after it was shown to double heart attack risk among patients taking it 18 months or longer.
"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 of the U.S. Food and Drug Administration's Drug Safety and Risk Management Advisory Committee.
The new concerns have arisen from a 107-page study on patients who were followed for one year after they discontinued taking Vioxx. The report states that 28 people from the study had heart attacks and strokes within one year after they stopped taking Vioxx. This is compared with 16 patients from the trial that had taken placebos.
Dr. Furberg's examination of the full report shows that seven Vioxx users had strokes, while two Vioxx users had mini-strokes (TIAs) in the year-long follow-up period. The placebo group experienced no strokes or TIAs.
"These data raise some very important questions, because for a while we assumed Vioxx caused temporary problems. It could be causing permanent damage," Furberg said."In the past we weren't quite sure of the stroke risk, so stroke is now back on the agenda in a bigger way."
Risks for short-term users?
This has left many short-term Vioxx users wondering what risks they may face down the line, as the result of a handful of prescriptions they filled for a then-FDA approved painkiller.
"Did Merck know about this risk before my doctor did... before the FDA did? My doctor and I assumed it was tested and safe, at least for short time use," asked Janet of Detroit.
New Merck painkiller rejected by FDA
Interestingly, Merck's original FDA application for Arcoxia was pulled in 2002, a full two years before the Vioxx recall.
Warren Wexelman of Maimonides Medical Center in Brooklyn (which banned Vioxx long before it was withdrawn), was not surprised by the FDA's findings: "Why should I think Arcoxia is any safer than Vioxx coming from the same group of people?" he asked.
Vioxx Legal Help
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