October 27, 2002 TOKYO (AP) -- 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 Sunday.
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.
On Oct. 15, AstraZeneca issued a safety warning to doctors after the company received reports of severe side effects in 22 patients, including 11 who died, Muramoto said. At a press conference later that day, the company raised those figures to 26 affected patients, including 13 deaths.
At that point, she said, the company had reports of 65 cases of side effects, including 27 deaths, but had not gone through all the cases to confirm their link to the drug. She said the company reported only the confirmed cases at the news conference, and it took it 10 more days to give the final results to the health ministry.
Muramoto said the company had reported the figures within the 30 days required by law and had no intention of concealing the problems.
"But the health ministry has made it clear they are not happy with the slow pace of reporting cases,'' Muramoto said, adding that the company was trying to speed up its filings.
Copyright 2002 The Associated Press. All rights reserved.
