Reactions 485 - 22 Jan 1994

Cancer drug approval criticisedPublic criticism has arisen in Japan over the approval

of the new antineoplastic agent, irinotecan, for thetreatment of lung, uterine and ovarian cancer.

Irinotecan was approved by the CentralPharmaceutical Affairs Council last month, despite thefact that 20 patients died after receiving the agent inclinical trials. The deaths were attributed to adverseeffects such as diarrhoea and leucopenia.

Prior to this report, there was also a report of 14patients who had died after taking a new drug forshingles, sorivudine, combined with an antineoplasticagent.

In an attempt to alleviate public criticism, Japan’sministry of health and welfare may disclose itsevaluation procedure for new drugs to hospitals andmedical associations.Terazono E. Tokyo may act in drugs row. Financial Times : 3, 8-9 Jan1994 800243326

» Editorial comment: Irinotecan was jointly developed byYakult Honsha and Daiichi and will be distributed by these 2companies as Campto® and Topotecin® injections, respectively.

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Reactions 22 Jan 1994 No. 4850114-9954/10/0485-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved