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Arava and Liver Damage
There is growing concern over
Arava's effects on the liver. High levels of liver enzymes
occur in up to 5% of Arava patients. The American College
of Rheumatology last summer warned doctors to take special
care by repeatedly testing patients' livers for signs of harm
and high levels of liver enzymes. But there is evidence that
Arava cause serious liver problems.
European health officials reported that over 200 Arava patients
have suffered liver problems after taking Arava. The European
Agency for the Evaluation of Medicinal Products issued an
urgent warning last year to patients and doctors about the
drug's toxicity. In the U.S., the consumer group Public Citizen
has petitioned the Food and Drug Administration (FDA) to remove
Arava from the market.
Arava was first marketed in the United States in September
1998 to treat rheumatoid arthritis. Over the next three years,
the FDA received reports of at least 130 cases of severe liver
toxicity, including 56 hospitalizations and twelve deaths.
Two of the people who died were in their twenties.
Arava and Methotrexate
Since Arava and methotrexate (an older drug also used to treat
rheumatoid arthritis) work equally well, and methotrexate
also bears a warning about possible liver damage, Public Citizen's
Health Research Group compared the two. There were six times
more cases of liver damage among Arava users than methotrexate
users - even though there were 6.8 million (5.5 times) more
prescriptions filled for methotrexate than Arava during that
time.
Public Citizen's petition is supported by Dr. David E. Yocum,
former chair of the FDA's Arthritis Drugs Advisory Committee.
Yocum said he agrees that Arava should be withdrawn from the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
Public Citizen. "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."
Arava and Liver Damage
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