Dinkes & Schwitzer are currently investigating
claims that the prescription arthritis drug Arava (leflunomide),
manufactured by Aventis, has caused severe liver complications including
deaths among patients. Estimates indicate over 1.5 million prescriptions
were written in the United States alone since Arava’s introduction
in September 1998.
Manufactured by Hoechst Marion Roussel since
1998,
Arava is used to treat active rheumatoid arthritis in adults to
reduce signs and symptoms and to slow down damage to joints. A
few
of the side effects that may occur include:
Diarrhea
Hair loss
Rash
Elevated liver enzymes
In March 2002, the non-profit consumer advocacy group,
Public Citizen, petitioned the United States Food and Drug Administration
(FDA) for the immediate removal of Arava from the market due to
serious adverse side effects that include liver toxicity and liver
failure leading to death. The petition stated there had been at
least 130 cases of severe liver toxicity reported to the FDA, including
56 hospitalizations and 22 deaths. Liver toxicity induced by Arava
is a suspected cause in at least 12 of those deaths.
Studies have
shown that when compared to a possibly
more effective alternative arthritis drug called methotrexate,
patients using Arava reported six times more cases of fatal liver
toxicity
and thirteen times more cases of hypertension. Interestingly, 5.5
times more prescriptions have been filled for methotrexate since
1998, than for Arava. Additionally, Arava has been associated with
at least 12 cases of Stevens-Johnson Syndrome, a life-threatening
autoimmune disease, while methotrexate has not.
An additional problem
in taking Arava is the extended length of time it remains in the
body compared to most drugs. Package
warnings suggest that Arava byproducts could remain in the body
for months. Consequently, even if a patient were to stop taking
Arava, serious side effects could continue to be revealed.
In clinical
trials performed for pre-marketing approval, reports clearly indicated
that Arava led to severe liver complications.
The surprisingly large number of reports of severe side effects
and deaths associated with Arava since FDA approval is tragic.
Patients
currently taking Arava for rheumatoid arthritis should talk to
their physician immediately and discuss your options.
If you or
a family member have taken Arava® and
would like more information concerning your legal rights, please contact
us.
Put proven injury lawyers on your side. Contact
Dinkes & Schwitzer at 1-800-933-1212 for
your free legal consultation.