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FDA BLACK BOX WARNING Pregnancy must be excluded before the start of treatment with Arava. Arava is contraindicated in pregnant women, or women of childbearing potential who are not using reliable contraception. Pregnancy must be avoided during Arava treatment or prior to the completion of the drug elimination procedure after Arava treatment. |
The New Zealand Centre for Adverse Reactions Monitoring reported in their March 2006 newsletter that there is increasing evidence...
FDA BLACK BOX WARNING Pregnancy must be excluded before the start of treatment with Arava. Arava is contraindicated in pregnant women, or women of childbearing potential who are not using reliable contraception. Pregnancy must be avoided during Arava treatment or prior to the completion of the drug elimination procedure after Arava treatment. |
The New Zealand Centre for Adverse Reactions Monitoring reported in their March 2006 newsletter that there is increasing evidence that the arthritis drug leflunomide (ARAVA), taken alone or in combination with another drug, methotrexate (TREXALL), can case serious lung inflammation called pneumonitis. This illness is characterized by difficult breathing, a deficiency of oxygen reaching the body, and lung infiltrates.
Leflunomide is produced by Aventis Pharmaceuticals Inc. of Kansas City, MO and was approved by the Food and Drug Administration (FDA) in September 1998 for the treatment of active rheumatoid arthritis in adults. On Mar. 28, 2002, Public Citizen petitioned the FDA to immediately remove leflunomide from the market because of its toxicity to the liver (see Worst Pills Best Pills News June 2002 ).
The New Zealand authorities have received seven reports of pneumonitis occurring in patients taking leflunomide, all of whom were also taking methotrexate. Four patients were women and three were men. Their ages ranged from 43 to 83 years. Their initial symptoms were varied, but included difficult breathing, cough, fever, lethargy, weight loss, and flu-like symptoms. Two of the patients were admitted to the intensive care unit and required a machine to help them breathe (a ventilator).
Methotrexate by itself can cause pneumonitis, usually within the first year of use. These seven patients had each been using leflunomide for between 12 and 36 weeks. Most had been taking methotrexate for a longer period of time. Four patients had been taking leflunomide for more than one year. This supports a cause-and-effect role for leflunomide, rather than methotrexate, in the development of pneumonitis in these patients.
The New Zealand authorities estimated that by 2004, approximately 400,000 patients had received leflunomide worldwide. The reported incidence of pneumonitis was one in 5,000. However, the true incidence may be much higher. In a post-marketing safety surveillance program in Japan, 29 of 3,658 patients who were taking leflunomide developed pneumonitis, and 11 died.
What You Can Do
If you are taking leflunomide, either alone or in combination with methotrexate, and you experience difficulty breathing, a dry cough, and dizziness, you should contact your physician immediately.
