Anti-cancer drug kills 124 in Japan
Side effects from the cancer-fighting drug Gefitinib have resulted in 124 deaths in Japan, a government official said today.
The dead were among 494 patients who have developed debilitating lung disorders, including pneumonia, blamed on the drug, according to Toshihito Ikeda of the Health and Welfare Ministry.
The figure is up from 39 deaths acknowledged in October by the drug’s manufacturer, Anglo-Swedish pharmaceutical giant AstraZeneca. Gefitinib has been taken by at least 10,000 cancer patients since it was cleared for use in Japan in July.
Japan is the only country to approve Gefitinib as treatment for advanced non-small-cell lung cancer. It is sold in Japan under the Iressa brand.
The US Food and Drug Administration and Swiss health authorities are reviewing AstraZeneca’s application to sell the drug in those countries.
Early studies showed lung cancer patients who had not been helped by other therapy recovered impressively after taking Iressa, but the large number of severe side effects prompted AstraZeneca to issue a safety warning to Japanese doctors in October.
A Health and Welfare Ministry panel today issued its own guidelines for prescribing Iressa. Among them, it directed doctors to thoroughly explain the risks of taking the drug to patients and their families. The panel also instructed doctors to hospitalise patients while they are being treated so they can be closely monitored.
AstraZeneca spokeswoman Fumiko Muramoto said the company could not comment until it had reviewed the ministry’s findings and recommendations. She said, however, the figures appeared to be accurate and based on the company’s own reports.
