Merck & Co’s arthritis pill Vioxx was pulled from market
shelves over health risks in 2004, after a study showed the drug increased the
risk of heart attacks and strokes twice if it was taken for more than 18
months.
Now a new long-tern follow-up study appears to back previous
findings, namely the drug nearly doubles the risk of heart attack and stroke
compared to no treatment at all. Moreover, the risk persists for approximately
a year, according to Dr. Robert Bresalier, a professor of medicine at the M.D. Anderson
Cancer Center
in Houston and
co-author of the study. The good news is “the risk goes back toward normal
after a year of follow up” he added.
For the study, Dr. Bresalier and colleagues followed people
who had participated in the international APPROVe trial, which compared Vioxx
to placebo over 3 years in an attempt to see whether the drug could reduce the
recurrence of cancerous colon polyps. The study was stopped early in 2004
because of the increased risk for heart attacks and strokes.
Almost 2,600 people were involved in the trial. The
researchers succeeded to contact 84 percent of them and found that a year after
finishing Vioxx treatment, those given the pill had a 79 percent increased risk
of heart attack, stroke compared with those who had received placebo. Also,
their relative risk of death was 31 percent higher.
“Our data are compatible with an early increase in risk that seems to
persist for about one year after three years of treatment. The cardiovascular
toxicity seems to be a class effect. Indeed, studies of other selective COX-2
inhibitors reported similar findings,” the researchers concluded. Cox-2 drugs
were designed to be safer replacements for NSAIDS, including aspirin and
naproxen, which can cause deadly gastrointestinal bleeding.
A statement released by Doug Watson, a cardiovascular
epidemiologist and senior director at Merck Research Labs says the overall
findings were consistent with the original study, but the company officials
believe that the research “using limited data from a prematurely terminated
study needs to be interpreted very cautiously and in the context of the rest of
the data from the extensive clinical development program for Vioxx.”
Last year, Merck paid 4.85 billion dollars to settle 27,000
lawsuits filed by people saying they or their family members suffered injury
from Vioxx painkiller drug. As of Oct. 9, 2007, in the United States,
the Company had been served or was aware that it had been named as a defendant
in approximately 26,600 lawsuits, filed on or before Sept. 30, 2007, which
include approximately 47,000 plaintiff groups, alleging personal injuries
resulting from the use of Vioxx.
Vioxx had generated sales of $2.5 billion a year before the
arthritis and chronic pain pill was withdrawn from U.S. drugstores in 2004.
The study was published online in the Oct. 14 issue of British
medical journal The Lancet.