Arava News
- March 29, 2002
Rheumatoid arthritis drug Arava (leflunomide) is linked to
at least 12 liver
failure deaths.
Public Citizen filed a petition to the FDA urging them to review
the unexpected deaths and serious illnesses that have been attributed
to the use of Arava (leflunomide). Former FDA scientific adviser
Dr. David Yocum supports Public Citizen's petition because "here
we have 12 deaths, and these patients died very quickly. All I can
say is, this needs to be reviewed."
Public Citizen's petition followed the February 2001 European Agency
for the Evaluation of Medical Products warning issued to doctors
and patients citing nine liver failure deaths in Arava patients.
Two months following, Arava manufacturer Aventis Pharmaceuticals
issued a warning letter to physicians. Last August, the American
College of Rheumatology then published a warning to doctors and
patients urging a monthly blood test be performed in an Arava patient's
first six months with follow up tests every two to three months
after. Yocum said he has never supported taking a drug off the market,
"but it's kind of scary, what we see." (MSNBC, 3-29-02)
- March 28, 2002
Public Citizen asks FDA to immediately ban Arava.
Consumer advocacy group Public Citizen urged regulators to immediately
ban Aventis' rheumatoid arthritis drug Arava (leflunomide) due to
the link to 12 fatal cases of
liver failure. Public Citizen finds the risks of Arava to outweigh
its benefits that have proven to be no more effective or beneficial
than older, commonly used treatments.
The FDA has received 130 reports of severe liver problems in Arava
patients since the drug's 1998 U.S. debut. Reports of lymphoma and
drug induced hypertension in Arava patients, as well as blood and
gastrointestinal reactions leading to hospitalizations have been
found, according to Public Citizen. Director of Arizona Arthritis
Center and former scientific adviser to the FDA, Dr. David Yocum,
also agrees that Arava should be pulled from the market. Yocum has
treated a patient on Arava that died from liver failure, and he
finds Public Citizen's data to be "idiosyncratic and unpredictable".
The resulting deaths and serious Arava side effects associated
to the rheumatoid arthritis drug appears to have had warning that
may have prevented these incidents from occurring. In February 2001,
the European Medicines Evaluation Agency warned of severe liver
reactions with some fatal outcomes occurring in Arava patients.
The agency said a total of 296 liver reactions had been reported
by that time with 129 cases considered serious and nine having a
fatal outcome. (Reuters, 3-28-02)
- March 28, 2002
Rheumatoid arthritis drug Arava may cause liver
damage.
Public Citizen wants rheumatoid arthritis drug Arava banned because
of the dozens of serious liver injuries and 12 deaths linked to
the drug's use. After the 1998 FDA approval, the FDA did state that
Arava worked no better than the older drug, competitor methotrexate,
but it know provided patients with different options. The FDA has
now received at least 130 reports of severe liver toxicity linked
to Arava use, and this includes 56 hospitalizations and 12 deaths.
The FDA has six times more reports of liver damage among Arava users
than methotrexate users, despite methotrexate being prescribed 5.5
times more than Arava. (Yahoo, 3-28-02)
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