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 Adverse Cases

Back Reported Adverse Drug Reaction Cases
Is it leflunomide lung?

ADRAC continues to receive reports of severe pulmonary disease, including interstitial lung disease (ILD) in association with leflunomide. In some cases, the association with leflunomide was not recognised early enough and resulted in a fatal outcome.

Reports of ILD with leflunomide alone or in combination with methotrexate (also unilaterally associated with ILD) were described in two previous Bulletins.1,2 In Dec 2006, 142 of the 699 reports with leflunomide described respiratory symptoms including 22 of ILD. In June 2009, the number of leflunomide reports has increased to 845, 196 of which describe respiratory symptoms including 39 of ILD. Of the 196 reports describing respiratory symptoms, 153 (78%) described concomitant use of methotrexate; 23 of the 39 ILD reports involved this combination.

Although clinically variable, manifestations of drug-induced pulmonary toxicity commonly include fever, cough (especially dry and non-productive), dyspnoea, pleurisy, chest pain, hypoxaemia and/or radiological evidence of pulmonary infiltrates (usually diffuse and/or alveolar).

New onset or worsening pulmonary symptoms with or without associated fever in those taking leflunomide with or without methotrexate may indicate development of leflunomide lung and should prompt further investigation.

If ILD develops, discontinuation of these therapies and implementation of a washout with cholestyramine (as recommended in the leflunomide Product Information) may be appropriate.3

In addition to ILD, leflunomide and methotrexate are both associated with a number of other severe, potentially fatal adverse effects, including liver failure, Stevens-Johnson syndrome and agranulocytosis. It is expected that the risks for ILD and other severe toxicities would be at the least additive when these drugs are used concomitantly.

Patients taking leflunomide, methotrexate or a combination of these should be monitored closely and informed about the possible early warning signs of toxicity, including ILD. They should be given Consumer Medicine Information for the prescribed drugs and advised to remain vigilant for signs that suggest a possible adverse reaction/s. Patients should contact their physician as soon as possible if these symptoms appear or worsen during therapy.

  1. Leflunomide: serious hepatic, blood, skin and respiratory reactions Aust Adv Drug Reactions Bull 2001; 20(2).
  2. . 2.Leflunomide and interstitial lung disease.Aust Adv Drug Reactions Bull 2006; 25(6).
  3. Arava, Arabloc (leflunomide) Product Information. Sanofi-Aventis Australia Pty Ltd.
Australian Adverse Drug Reactions Bulletin
Volume 28, Number 4, August 2009


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