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Prior to Arava’s approval methotrexate was available
to treat rheumatoid arthritis. The
FDA stated when approving Arava that Arava did not treat
rheumatoid arthritis any better than existent medications
but approval of Arava would provide more treatment options.
Arava has been associated to six times as many reports of
liver damage as well as more reports of lymphoma, high blood
pressure, and Stevens-Johnson syndrome. The death rate in
Arava users is 33 times higher than methotrexate according
to Public Citizen figures.
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Arava Dangers
Arava has been identified as a dangerous drug due to the inability
to predict which patients are at risk for the life-threatening
complications associated to the rheumatoid arthritis medication,
described as “idiosyncratic and unpredictable” by
a former head of the FDA advisory panel reviewing arthritis
drugs.
Arava was reported to have severe liver reactions by the
European Medicines Evaluation Agency in February 2001. The
agency warned that there had been a total of 296 liver reactions
at that time, with 129 cases considered to be serious and
nine resulting in death. The concern at the speed the 12 Arava
patients died is another indicator that Arava action must
be taken, which was identified by the European Agency to occur
within six months of taking the drug.
What is Rheumatoid Arthritis (RA)?
The Arthritis Foundation identifies rheumatoid arthritis (RA)
as an inflammation in the lining of the joints and/or other
internal organs that affects many different joints. Rheumatoid
arthritis can be chronic or a disease of flares and remissions
that affects the entire body. RA is characterized by the inflammation
of the membrane lining the joint that causes pain, stiffness,
warmth, redness, and swelling. The inflamed joint lining can
invade and damage bone and cartilage and inflammatory cells
release enzymes that can digest bone and cartilage. The joint
that is involved can end up losing its shape and alignment
and resulting in pain and loss of movement.
Arava Versus Methotrexate
The Public Citizen’s petition said that methotrexate
was prescribed at a rate more than five times higher than
Arava but methotrexate was associated with just two liver
deaths opposed to up to 22 deaths associated to Arava in the
same period.
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Public Citizen Petitions Ban of Arava
Public Citizen petitioned the FDA for the immediate removal
of Arava from the market on March 28, 2002. Arava has been
linked to liver failure and to an autoimmune disorder called
Stevens-Johnson, as well as lymphoma, high blood pressure,
and skin, blood, and gastrointestinal reactions serious enough
to lead to hospitalization. Rheumatoid arthritis affects over
2 million Americans.
| “Public Citizen, representing 135,000 consumers
nationwide, hereby petitions the Food an Drug Administration
pursuant to the Federal Food, Drug and Cosmetic Act 21,
U.S.C. Section 355, and C.F.R. 10.30, to immediately
remove from the market Arava (leflunomide; Aventis),
a drug for the treatment of rheumatoid arthritis. From
when it was first marketed in late September 1998 through
September 2001, Arava has been associated with at least
130 severe hepatic reactions including 56 hospitalizations
and 22 deaths, two of whom were patients in their
twenties. For 12 of these deaths, leflunomide-induced
liver toxicity appears to be the most plausible explanation.
Similar serious reactions have caused the European Agency
for the Evaluation of Medicinal Products to issue an urgent
warning to patients and physician concerning the potential
causal relationship of leflunomide to severe liver
injury, including death.” |
The petition went on to conclude that:
| “Leflunomide offers no advantages to patients with
rheumatoid arthritis since it lacks any increased efficacy
and appears to pose an increased likelihood of serious
adverse events such as liver toxicity when compared
to methotrexate, the current gold standard. The extremely
long half-life from which there is no proven escape is
another deterrent to use. ‘Dear Healthcare Professional’
letters are not a solution; they have not been shown to
work to protect patients from serious adverse events.
With a variety of better drug treatments available, there
is no reason to subject patients to an accumulating list
of added risks; leflunomide should be promptly removed
from the market.” |
To view the petition to ban Arava, click
here.
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