Arava Questions

• What is Arava?
• When did the FDA approve Arava?
• What Arava side effects have been associated to the rheumatoid arthritis drug?
• What is the 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 the FDA approve Arava?
First approved by the FDA in September 1998, Arava has now been used by more than 200,000 patients.

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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.

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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.

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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." To learn more about your legal rights and any Arava side effects you have experienced, please contact us.

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