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A prescription arthritis drug
has been linked to an alarmingly high number of severe liver problems,
including deaths, since it came to the market in 1998 and should be taken
off the market immediately, the consumer group Public Citizen said today
in a petition to the Food and Drug Administration (FDA).
Arava, also known as leflunomide
and produced by Aventis, was first marketed in the United States in September
1998 to treat rheumatoid arthritis. Over the next three years, it was
associated with at least 130 cases of severe
liver toxicity, including 56 hospitalizations and 12 deaths,
according to FDA data. Two of those who died were in their 20s.
"To have this many deaths
and severe reactions over such a short time is truly disturbing,"
said Dr. Sidney Wolfe, director of Public Citizen's Health Research Group,
which submitted the petition. "When there are other treatments that
are more effective and don't endanger patients as much as this drug, there
is absolutely no reason for the FDA to keep Arava on the market."
In a comparison between Arava
and methotrexate, which is an equally or more effective drug for treatment
of rheumatoid arthritis, Public Citizen found that over the three-year
period it has been on the market, Arava was linked to six
times more cases of fatal liver toxicity and 13 times more reports of
hypertension than methotrexate, although there were 6.8 million
(5.5 times) more prescriptions filled for methotrexate than Arava during
that time. Additionally, Arava has been associated with 12 cases of the
life-threatening autoimmune disease Stevens-Johnson Syndrome, and methotrexate
with none.
Another danger of the drug
is that it remains in body tissues for
an extremely long time. Warnings already on its packaging suggest
that byproducts could remain in the body for months, so that even if patients
stopped the drug after an adverse reaction started, the damage could continue
to affect patients for months.
Public Citizen's petition is
supported by Dr. David E. Yocum, director of the Arizona Arthritis Center
at Arizona Health Sciences Center, who recently ended a tenure as chair
of the FDA's Arthritis Drugs Advisory Committee. Yocum said he agrees
that the drug should be withdrawn from the market.
"I do not believe that
the general rheumatologist understands or has any knowledge about these
serious and potentially life-threatening complications," Yocum said
in a letter to Wolfe. "I also agree that providing a black box warning
concerning these issues may not be effective since no one can predict
who will suffer from these complications."
Yocum has recently reported
to the FDA the death of one of his patients from acute liver failure after
using Arava.
After similar serious reactions
to leflunomide in Europe, the European Agency for the Evaluation of Medicinal
Products issued an urgent warning
last year to patients and doctors about the drug's toxicity.
"Before it was approved
by the FDA, there was evidence that leflunomide led to liver complications,
and now the dangers are even clearer," Wolfe said. "No more
patients should be subjected to these risks."
Public
Citizen March 28, 2002
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