cancer drug approval criticised

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DRUG REACTIONS Public criticism has arisen in Japan over the approval of the new antineoplastic agent, irinotecan, for the treatment of lung, uterine and ovarian cancer. Irinotecan was approved by the Central Pharma- ceutical Affairs Council last month, despite the fact that 20 patients died after receiving the agent in clinical trials. The deaths were attributed to adverse effects such as diarrhoea and leucopenia. Prior to this report, there was also a report of 14 patients who had died after taking a new drug for shingles, sorivudine, combined with an anti- neoplastic agent. In an attempt to alleviate public criticism, Japan's ministry of health and welfare may disclose its evaluation procedure for new drugs to hospitals and medical associations. Terazono E. Tokyo may act in drugs row. Financial Times: 3. 8·9 Jan 1994 Editorial comment: Irinotecan was jointly developed by Yakult Honsha and Daiichi and will be distributed by these 2 companies as Campto® and Topotecin® injections. respectively. 0156.270319410921.0021/$01.00° Adis International Limited 1994. All rights reserved 21 INPHARMA'" 22 Jan 1994

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Page 1: Cancer drug approval criticised

DRUG REACTIONS ~r~approvrucriti~

Public criticism has arisen in Japan over the approval of the new antineoplastic agent, irinotecan, for the treatment of lung, uterine and ovarian cancer.

Irinotecan was approved by the Central Pharma­ceutical Affairs Council last month, despite the fact that 20 patients died after receiving the agent in clinical trials. The deaths were attributed to adverse effects such as diarrhoea and leucopenia.

Prior to this report, there was also a report of 14 patients who had died after taking a new drug for shingles, sorivudine, combined with an anti­neoplastic agent. In an attempt to alleviate public criticism, Japan's ministry of health and welfare may disclose its evaluation procedure for new drugs to hospitals and medical associations. Terazono E. Tokyo may act in drugs row. Financial Times: 3. 8·9 Jan 1994

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

0156.270319410921.0021/$01.00° Adis International Limited 1994. All rights reserved

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INPHARMA'" 22 Jan 1994