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What
is Arava?
When did
Arava receive FDA approval?
What side
effects are linked to Arava rheumatoid arthritis drug?
Is there
a difference between Arava and competitor methotrexate to
treat rheumatoid arthritis?
What is rheumatoid
arthritis?
How many
people does rheumatoid arthritis affect?
What is liver
failure?
What is
Stevens-Johnson syndrome?
Why has
a petition been sent to the FDA to ban Arava?
Were there previous signs that Arava was
associated to serious and potentially fatal adverse effects?
What are
my legal rights regarding Arava side effects?
What is Arava?
Arava is a prescription drug for rheumatoid arthritis that
has recently been linked to 130 cases of severe liver problems
(hepatoxicity) and up to 22 deaths since it has been on the
market. Arava is manufactured by Aventis Pharmaceuticals and
is also known as leflunomide.
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When did Arava receive FDA approval?
Arava was FDA approved in September 1998 and has so been
used by more than 200,000 patients.
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What side effects are linked to Arava rheumatoid
arthritis drug?
Arava has been linked to life threatening conditions including,
fatal liver failure, hypertension, and life-threatening autoimmune
disease Stevens-Johnson syndrome. Arava is especially dangerous
because it remains in the body tissues for an extended amount
of time, allowing adverse effects to surface even after patients
have discontinued their use of Arava.
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Is there a difference between Arava and competitor
methotrexate to treat rheumatoid arthritis?
The FDA noted upon approval that Arava worked no better than
methotrexate but it provided more options to patients. Sidney
Wolfe, of the consumer advocacy group Public Citizen, compared
the two arthritis drugs and found there have been six times
more FDA reports of liver damage with Arava patients versus
methotrexate patients. There have also been more FDA records
of lymphoma, high blood pressure, and a life-threatening autoimmune
disorder Stevens-Johnson syndrome in Arava patients than methotrexate
patients. Despite numbers showing there have been 6.8 million
more prescriptions filled for methotrexate than Arava, the
number of adverse effects remains higher in lenflunomide users.
Public Citizen has found the death rate is 33 times higher
in Arava users.
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What is rheumatoid arthritis?
Rheumatoid arthritis (RA) involves inflammation in the lining
of the joints and other internal organs. Unlike other types
of arthritis that normally affects the elderly, rheumatoid
arthritis’ onset is between ages 25 and 50.
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How many people does rheumatoid arthritis
affect?
About two million Americans suffer from rheumatoid arthritis,
the majority of those affected being women.
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What is liver failure?
Liver failure, or hepatoxicity, can result from prescription
drug use and occurs when a large part of the liver has become
damaged beyond repair. Arava has been linked to at least 12
deaths due to liver failure amongst other serious liver problems.
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What is Stevens-Johnson syndrome?
Stevens Johnson Syndrome is an extreme allergic reaction,
usually to a drug, and has been associated to the rheumatoid
arthritis drug Arava. This autoimmune disease often leads
to severe morbidity and death.
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Why has a petition been sent to the FDA to
ban Arava?
The U.S. consumer advocacy group Public Citizen urged regulators
to immediately ban rheumatoid arthritis drug Arava (leflunomide)
because of the link between the prescription drug and 12 fatal
cases of liver failure. Public Citizen said that the risks
of Arava outweigh its benefits.
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Were there previous signs that Arava was
associated to serious and potentially fatal adverse effects?
In February 2001, the European Agency for the Evaluation
of Medical Products issued a warning to doctors and patients
citing nine deaths due to liver failure in Arava patients.
Two months after that, Arava manufacturer Aventis Pharmaceuticals
issued a warning letter to physicians. Last August, the American
College of Rheumatology published a warning to doctors and
patients urging monthly blood tests be taken in an Arava patient’s
first six months and follow-up tests every two to three months
following. If you have suffered from the use of prescription
drug Arava, contact us to learn your rights.
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What are my legal rights regarding
Arava side effects?
From Arava’s arrival to the market there have been studies
showing the adverse effects that can occur in Arava patients.
In addition, Arava is not viewed as having any superiority
over other rheumatoid arthritis prescriptions it simply provided
patients “more options.” If you wish to learn more
about Arava
contact us to speak directly with an Arava attorney.
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