OSAKA -- A cancer drug blamed for more than 120 deaths in Japan was administered to 296 patients before the health ministry approved it last July, with one dying of side effects in May, pharmaceutical company officials said Thursday.
Three other patients were also in serious condition between January and April before the Health, Labor and Welfare Ministry approved the anticancer drug gefitinib, according to AstraZeneca K.K., an affiliate of London-based international pharmaceutical firm AstraZeneca PLC.
The Osaka-based affiliate said it distributed the product to 89 hospitals across the nation starting in March 2001, only charging shipping costs.
Fumiko Muramoto, a spokeswoman for the affiliate, said the provision was part of a worldwide program of the AstraZeneca group and there were requests for the product in Japan.
Pharmaceutical companies are not allowed to provide unauthorized drugs in Japan, but this case does not violate any laws as it may be considered an act by doctors, according to the ministry.
The health ministry gave swift approval -- the first worldwide -- for the importation of the drug. Doctors have been instructed to take special precautions in administering the drug, which is able to prevent the functions of receptors linked with cancer-cell multiplication by targeting molecules.
About 18,000 cancer patients were treated with the drug, but controversy has raged ever since it was discovered that 124 people have died from side effects, including pneumonia, after the drug was approved, according to the ministry.