The health ministry has ordered AstraZeneca K.K., the importer of the controversial lung cancer drug Iressa, to include a patient form with the medicine clearly stating the possibility of fatal side effects, ministry sources said Tuesday.
It is the first time the ministry has ordered a drug firm to make explicit the possibility that a drug may have life-threatening effects in a patient form.
It is also extremely rare for the government to order a drug firm to directly inform patients about side effects. Pharmaceutical firms have usually been told to provide such information to doctors.