Arava Lawsuit

What is Arava?
Arava is an anti-inflammatory prescription drug for rheumatoid arthritis. Arava side effects have recently been linked to 130 cases of severe liver problems (hepatoxicity) and up to 22 deaths since it has been on the market. Arava, FDA approved in September 1998, is manufactured by Aventis Pharmaceuticals and is generically known as leflunomide. Aventis reported profits of $225 million for Arava in worldwide sales for 2001.

FDA Arava Reports
In just three years after Arava debuted in the U.S. the FDA received reports of liver damage and other Arava side effects including:

• 130 reports of severe liver toxicity
• 56 of these cases resulted in hospitalization
• 12 of these reports resulted in death
• 2 of the Arava patients that died were in their 20s

Arava Side Effects

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• Arava Side Effects & Liver Failure
  

• Arava Side Effects & Stevens-Johnson Syndrome
  

• Arava Side Effects

The purpose of the liver is to process harmful substances, aid in the digestive process, and produce cholesterol. Liver failure, or hepatoxicity, mostly occurs when a large part of the liver has become damaged beyond repair. Prescription drugs can cause liver failure, and Arava has been reported to cause 12 deaths due to liver failure. Most instances of liver failure require a liver transplant in order to avoid death. The FDA has six times more reports of Arava liver damage than in methotrexate users despite thousands more people using the older rheumatoid drug.

After the European News first warned patients and doctors of the toxicity of Arava in February 2001, the rheumatoid drug’s manufacturer issued a warning letter to physicians two months later. In August 2001, the American College of Rheumatology published warnings to doctors and patients urging monthly blood tests be taken in an Arava patient’s first six months on the rheumatoid drug along with follow-up tests every two to three months. But some doctors find this is not even enough because it is impossible to predict the Arava patients at risk. Arava can take months to completely dissipate, putting discontinued patients at risk for life threatening arava side effects as well.

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Arava Side Efftects & Stevens-Johnson Syndrome

Stevens-Johnson syndrome is an immune complex mediated hypersensitivity complex that is a severe expression of erythema multiforme. Many drugs often cause this syndrome, and it has recently been associated to the use of Arava. Stevens Johnson Syndrome is an extreme allergic reaction usually caused by a drug. Stevens-Johnson syndrome is a very serious systemic disorder often leading to severe morbidity and death.

In the Arava prescribing information, the following adverse reactions have been reported in the controlled studies performed on the rheumatoid arthritis drug, regardless of causality.

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Arava Side Effects

• Body as a whole: allergic reaction, asthenia, flu syndrome, infection, injury accident, pain, abdominal pain, back pain, abscess, cyst, fever, hernia, malaise, pain, neck pain, pelvic pain
• Cardiovascular: hypertension, chest pain, angina pectoris, migraine, palpitation, tachycardia, varicose vein, vasculitis, vasodilatation
• Gastrointestinal: anorexia, diarrhea, dyspepsia, gastroenteritis, abnormal liver enzymes, nausea, GI/abdominal pain, mouth ulcer, vomiting, cholelithiasis, colitis, constipation, esophagitis, flatulence, gastritis, gingivitis, melena, oral moniliasis, pharyngitis, salivary gland enlarged, stomatitis, tooth disorder
• Endocrine: diabetes mellitus, hyperthyroidism
• Hemic and lympathic system: anemia, ecchymosis
• Metabolic and nutritional: hypokalemia, weight loss, creatine phosphokinase increased, hyperglycemia, hyperlipidemia, peripheral edema
• Musculo-skeletal system: arthralgia, leg cramps, joint disorder, synovitis, tenosynovitis, arthrosis, bone necrosis, bone pain, bursitis, muscle cramps, myalgia, tendon rupture
• Nervous system: dizziness, headache, paresthesia, anxiety, depression, dry mouth, insomnia, neuralgia, neuritis, sleep disorder, sweating increased, vertigo
• Respiratory system: bronchitis, increased cough, respiratory infection, pharyngitis, pneumonia, rhinitis, sinusitis, asthma, dyspnea, epistaxis, lung disorder
• Skin and appendages: alopecia, eczema, pruritus, rash, dry skin, acne, contact dermatitis, fungal dermatitis, hair discoloration, hematoma, herpes simplex, herpes zoster, maculopapular rash, nail disorder, skin discoloration, skin disorder, skin nodule, subcutaneous nodule, ulcer skin
• Special senses: blurred vision, cataract, conjunctivitis, eye disorder, taste perversion
• Urogenital system: urinary tract infection, albuminuria, cystitis, dysuria, hematuria, menstrual disorder, prostate disorder, urinary frequency, vaginal moniliasis

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