Tokyo, Oct 27: Side effects from the cancer-fighting drug Gefitinib have now caused 39 deaths in Japan, a spokeswoman for the Anglo-Swedish manufacturer, Astrazeneca PLC, said today. The drug has caused debilitating lung injuries such as interstitial pneumonia in 125 patients, including the 39 who have died, said spokeswoman Fumiko Muramoto.
“We knew about the possibility of these side effects from our clinical trials,” said Muramoto. “But the number of safety incidents is increasing very rapidly. It's alarming and that's why we're issuing the warnings.” Japan is the only country that has approved Gefitinib for advanced non-small-cell lung cancer. The U.S. Food and Drug Administration and Swiss health authorities are reviewing Astrazeneca's application to sell the drug in those countries.
Gefitinib, sold under the Iressa brand, has been taken by at least 10,000 cancer patients since it was cleared for use in Japan in July, Muramoto said.
She said that Japan's health, welfare and labor ministry plans to investigate the firm's Osaka-based Japanese subsidiary, but health ministry officials could not be reached for comment. Bureau Report