FDA
TALK PAPER

Food and Drug Administration
U.S. Department of Health and Human Services
Public Health Service 5600 Fishers Lane Rockville, MD 20857
FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available. 
T98-54                                          Print Media: 301-827-6242
September 11, 1998                              
                                                Consumer Inquiries:  800-532-4440

FDA APPROVES ARAVA FOR ARTHRITIS TREATMENT

FDA has approved Arava (leflunomide) the first oral treatment for active rheumatoid arthritis approved for slowing progression of this painful and disabling chronic disease. It is estimated that rheumatoid arthritis, an autoimmune disease, affects more than two million Americans.

Although the drug does not cure rheumatoid arthritis, it has been shown in clinical trials to provide relief for painful, swollen joints caused by rheumatoid arthritis and to retard damage to joints. The following may be used to answer questions.

Arava's ability to retard the progression of rheumatoid arthritis and to provide relief from the symptoms of this disease was shown in three controlled clinical trials involving more than 1700 patients of whom 800 received Arava. X-rays of hands, wrist and feet were used to assess the drug's effectiveness in reducing structural damage to joints. Much of this data was presented at an Aug. 7, l998, Arthritis Drugs Advisory committee, at which the committee unanimously recommended approval of Arava.

Because animal studies raised concerns that the drug can cause birth defects, a special warning included in the labeling states that Arava should never be used by pregnant women or women of childbearing age who are not using reliable contraception. Because the drug persists in the body for a long time, a drug elimination procedure is recommended for patients who want to become pregnant after taking Arava.

Adverse effects include risk of liver toxicity (hepatotoxicity), diarrhea, hair loss and rash. Physicians should monitor liver enzymes of patients taking Arava according to guidance in the labeling. Arava is not recommended in patients with significant liver disease.

The new drug, available in 10, 20 and 100 mg tablets (for a 3 day starting dose only), will be marketed by Hoechst Marion Roussel of Kansas City, MO.

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