Arava Side Effects - Stevens Johnson Syndrome, Liver Failure

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Arava Side Effects

Arava was originally considered to be a safer alternative to methotrexate, the commonly used rheumatoid arthritis drug used prior to Arava's approval. Methotrexate has been known for its severe side effects, but Arava has now been shown to have a death rate of 33 times higher than methotrexate patients and has had six times more reports of liver damage. These Arava figures do not even take in consideration the fact that methotrexate has been prescribed 5.5 times more than Arava. More than 200,000 rheumatoid arthritis patients have used Arava since the drug was released. Arava did not receive approval because of its superiority in treating rheumatoid arthritis over methotrexate but simply because the FDA wanted RA patients to have more treatment options.

Dr. Sidney Wolfe, director of Public Citizen consumer group, thinks that Arava should have never been approved because the drug's studies showed it contributed to elevated liver enzymes, which is usually a sign of damage to the organs. Public Citizen filed a 19-page petition to the FDA asking the ban of Arava from the market. The FDA said they would review the petition to determine if any action needs to be taken. Methotrexate is associated to just two liver deaths during the same period that Arava has been associated to 22 liver deaths.

Arava Liver Failure
Liver failure (hepatoxicity) is a side effect found amongst prescription drugs that has been linked to the use of Arava. Since Arava was approved in 1998 as a drug "no better than the older drug" meant to treat rheumatoid arthritis, there have been at least 130 reports of severe liver toxicity. The actual number of reported side effects that the FDA receives is estimated to be just 5-10% of the actual number of adverse effects experienced.

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 Arava patients at risk for life threatening side effects as well.

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.

Other 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

FAQ's

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Arava        Violations
October 23, 1998

Arava (leflunomide) manufacturer was sent a letter from the Department of Health and Human Services notifying them that The Division of Drug Marketing, Advertising and Communications reviewed their submissions and found they had violated the Federal Food, Drug, and Cosmetic Act. The FDA had identified violations in the following Arava materials:

• New Release (ID#98190106/
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• Media Alert (ID#98190105/
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• Dear Editor/Producer
  Letter (ID#98190101/
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• Video with Script (ID#98181101/
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