AstraZeneca PLC is reviewing how it dispenses a last-resort anticancer drug in Japan. The government claims the drug has been linked to 124 deaths.
The drug, Iressa, was administered only to those patients who did not respond to other treatments and whose cancer was at a very advanced stage, said Fumiko Muramoto, a spokeswoman for the pharmaceutical company.
"We have very rigid standards for when doctors use the drug," Muramoto said. "But we are taking some steps to review that." She would not elaborate.
AstraZeneca announced separately that the U.S. Food and Drug Administration has told the company it needs more time to review information about AstraZeneca's application to sell Iressa in the United States.
The FDA extended its review period by three months to May 5, even though the regulatory body's own Oncologic Drugs Advisory Committee recommended in September that it approve the drug, said Mary Lynn Carver, a spokeswoman at AstraZeneca's U.S. headquarters in Wilmington, Delaware.
AstraZeneca has already provided the FDA with data including safety information from clinical trials and commercial use of the medicine in Japan, Carver said. The drug, whose generic name is Gefitinib, is to be sold under the brand Iressa.
The Japanese government approved the drug last July, but in October the Health, Labor and Welfare Ministry issued a warning about potential side effects, which it said were linked to 124 deaths.
AstraZeneca issued a safety warning to doctors in October after the company received reports of severe side effects causing debilitating lung injuries.
The company said in October that Iressa's side effects had led to 39 deaths. But Muramoto said Thursday that a definitive link had not been proven, although it could not be ruled out.
Early studies showed lung cancer patients who had not been helped by other therapy recovered impressively after taking the drug.
AstraZeneca began offering Gefitinib free of charge to physicians at 89 clinics and hospitals for 286 patients in Japan in December 2000, the Asahi newspaper reported.
Although pharmaceutical companies aren't allowed to sell unapproved drugs in Japan, they can supply experimental drugs to doctors who request them for their own patients.
The doctors had agreed to take responsibility for prescribing it to their patients, Muramoto said.
Worldwide, about 22,000 people have used the drug, the Asahi newspaper said. Japan is the only country where it has been approved by federal health authorities.