Japan. The Safety Division of the Japanese Pharmaceutical and Food Safety Bureau has directed AstraZeneca to revise the labelling of their product Gefitinib, an antineoplastic agent, to include interstitial pneumonia in the warning section of the product insert. The company has also been directed to release this Emergency Safety Information to all medical institutions and health professionals. The above order was issued in view of the number of cases of pulmonary disorders, including interstitial pneumonia that have been reported with the drug since July 2002. The company has made the necessary revision and is in the process of distributing this safety information to the appropriate health sectors.
MHLW Press Release, 15 Oct 2002.