Japan criticised for unsafe drug licences

BMJ 1995; 311 doi: (Published 09 December 1995) Cite this as: BMJ 1995;311:1521

Japan's system for testing and licensing new medicines has come under fire after a spate of fatal reactions to drugs prescribed with official approval. A recent report by the ministry of health and welfare showed that four premature babies died and three became critically ill after being prescribed mefenamic acid to treat their patent ductus arteriosus. Another patient, suffering from idiopathic thrombosis, died after taking danazol, a drug approved for use in the treatment of certain types of infertility.

Critics of the ministry argue that these incidents are typical. …

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