Arava® Frequently Asked Questions

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Arava Update: On July 13, 2010, The U.S Food & Drug Administration (FDA) required the manufacturers of Arava to add a “Black Box Warning” to the package insert.  This is the most serious warning that the FDA requires and was added because of an increased risk of severe liver injury.

Arava FAQ

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.

What side effects have been associated with Arava?
According to medical professionals, the danger of Arava lies in its ability to remain in body tissue for an extremely long time. This means that if an Arava patient discontinues use of the drug therapy, they can continue to suffer serious side effects for months after. Seek medical attention right away if any of these severe side effects occur when using Arava: Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); Blistering or peeling skin; Blisters on the inside of eyes, nose, or mouth; Chest pain; Dark urine; Easy bruising/bleeding; Feelings of numbness or tingling; Fever; Infection; Muscle cramps (including leg cramps); Pale skin; Sore throat; Stomach pain; Unusual tiredness; Vomiting; Yellowing of the eyes or skin (jaundice).

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 is a chronic inflammatory disorder that most typically affects the small joints in your hands and feet. Unlike the wear-and-tear damage of osteoarthritis, rheumatoid arthritis affects the lining of your joints, causing a painful swelling that can eventually result in bone erosion and joint deformity.

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 patients suffer from inflammation of the skin and mucous membranes. Since mucous membranes are present in many organs throughout the body, such as the eyes, digestive system, lungs and respiratory system, many organs can become significantly affected during the disease process. SJS technically is an immune-complex-mediated hypersensitivity (allergic) condition. It is a severe expression of the condition known as erythema multiforme and is a lesser form of the condition known as toxic epidermal necrolysis. SJS is a serious disorder with potential for severe morbidity and in some cases, it can be fatal.

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