Japan. There has been one report of a death suspected to be caused by pancytopenia or pneumonia in a patient treated with imatinib mesylate (Glivec), an orphan drug approved in the treatment of chronic myeloid leukaemia in Japan. Based on this and other reports Japan’s Ministry of Health and Labor Welfare has advised the manufacturer (Novartis Pharma) to add pancytopenia, interstitial pneumonia and serious derma-tological symptoms (muco-cutaneous ocular syndrome, toxic epidermal necrosis, etc) to the Clinically Significant Adverse Reactions section for imatinib mesylate (Glivec). It is estimated that about 3000 patients have used imatinib mesylate (Glivec) since it was launched in December 2001.
Pharma Japan 1802/8 July 2002.