Vioxx Starts Adversely Affecting Patients After 4 Months, Not 18 Months
19 May 2006
Merck had initially claimed that Vioxx begins to have adverse effects on the cardiovascular system after 18 months' use, but data the company submitted to the FDA last week shows this starts to happen after just 4 months, according to the Wall Street Journal.
Dr. Eric Topol, who authored 16 articles on Vioxx and was behind the move to investigate the drug, says there has never been any data to back the theory that adverse effects started after 18 months' use.
A study carried out at McGill University, Montreal, Canada, and published in the Canadian Medical Journal, revealed that one quarter of Vioxx users who had a heart attack, had one within two weeks of starting treatment.
Many experts say there are effective alternative drug combinations which do not have the health risks of cox-2 inhibitors. They believe that Celebrex, the only cox-2 inhibitor on the market, may also hold risks for the patient.
According to the Wall Street Journal, new data shows that Vioxx was more dangerous than a placebo within four months of starting treatment - not significantly more dangerous, but enough to indicate that the danger started at 4 months, not 18 months of use.
Merck has always maintained that the risk of heart attack only happens after long-term use.
Merck is facing thousands of lawsuits from patients who took Vioxx and claim it caused them either to have a stroke or a cardiovascular event. With payouts of over $30 million per case it loses, the company could end up having to pay out billions of dollars in compensation.
Written by: Christian Nordqvist Editor: Medical News Today
