Label Changes for:

Rilutek (riluzole) tablets

November 2009

Changes have been made to the WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – November 2009

WARNINGS

Interstitial Lung Disease
  • Cases of interstitial lung disease (see ADVERSE REACTIONS) have been reported in patients treated with riluzole, some of them severe; upon further investigation, many of these cases were hypersensitivity pneumonitis. If respiratory symptoms develop such as dry cough and/or dyspnea, chest radiography should be performed, and in case of findings suggestive of interstitial lung disease or hypersensitivity pneumonitis (e.g., bilateral diffuse lung opacities), riluzole should be discontinued immediately. In the majority of the reported cases, symptoms resolved after drug discontinuation and symptomatic treatment.

PRECAUTIONS 

Information for the Patient
  • Patients should be advised to report any cough or difficulties in breathing to their physicians

ADVERSE REACTIONS

  • information regarding interstitial lung disease and hypersensitivity pneumonitis
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