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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.
When did the FDA approve Arava?
First approved by the FDA in September 1998, Arava has now been used by
more than 200,000 patients.
What Arava side effects have been associated to the rheumatoid arthritis
drug?
Arava has been linked to serious and life-threatening conditions including,
fatal liver failure, hypertension, and life-threatening autoimmune disease
Stevens-Johnson syndrome. Arava is also dangerous because it remains in
the body tissues for an extended amount of time. Patients who have discontinued
their use of Arava due to adverse effects can continue to experience the
symptoms because of this.
What is the difference between Arava and competitor methotrexate to
treat rheumatoid arthritis?
When the FDA first approved Arava, the agency noted it worked no better
than methotrexate, but it provided more options to patients. Sidney Wolfe,
director of the consumer advocacy group Public Citizen, compared the two
arthritis drugs and found the FDA has six times more reports of liver damage
with Arava patients than methotrexate patients. Wolfe also noted that FDA
records show more reports of lymphoma, high blood pressure, and a life-threatening
autoimmune disorder Stevens-Johnson syndrome in Arava patients than methotrexate
patients. There have been 6.8 million more prescriptions filled for methotrexate
than Arava, but still the number of adverse effects remains higher in lenflunomide
users. The death rate in Arava users is 33 times higher, according to Wolfe.
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.
How many people does rheumatoid arthritis affect?
About two million Americans suffer from rheumatoid arthritis, the majority
of those affected being women.
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.
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.
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.
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.
When FDA medical reviewer David Graham told lawmakers during a congressional hearing on the recall of Vioxx that drugs require stricter safety evaluations, he didn''t stop there. Graham named five other drugs currently on the market that he belie...
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