Anti-Cancer Drug May Be Fatal
Oct. 21, 1997
TOKYO (AP) _ The manufacturer of an anti-cancer drug has been ordered to warn doctors in Japan that 30 patients taking the medicine may have died of side effects.
The government order came after the Japanese unit of Pharmacia and Upjohn Inc. reported the deaths to Japan's Health and Welfare Ministry. The patients account for 4.2 percent of a 700-person group being monitored while receiving the drug, which is sold under the brand name Idamycin.
The drug is sold in the United States under the same name. Prior to approving its use, the U.S. Food and Drug Administration determined that the drug's potential benefits outweighed the risks. In the United States, the drug comes with strong warnings that it can cause serious, even fatal side effects.
``We've known the death rate is high for this kind of drug, but we want to make sure doctors and patients are also fully aware of the risks involved from possible side effects,'' Hiroshi Yamamoto of the ministry's pharmaceutical and medical bureau said Tuesday.
Although the drug may be dangerous, he said, ``without any treatment, many of the patients would die in a matter of weeks.''
In clinical trials before approval, 20 of 156 people treated with Idamycin died, Yamamoto said, a 12.8 percent death rate. It was not clear if the patients died of cancer or if their deaths were linked to the drug.
About 5,000 Japanese stricken with acute myelocytic leukemia have taken Idamycin since it was approved for sale in Japan two years ago, said Pharmacia and Upjohn spokeswoman Kyoko Sunada.