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.
The latest step was taken in response to complaints that doctors had prescribed the drug to patients without fully understanding its risks, the sources said.
Iressa, whose generic name is Gefitinib, is made by AstraZeneca PLC of Britain. It was approved in July for use in Japan and had been administered to about 23,500 people by the end of January.
Of 473 patients who later developed lung disorders, including interstitial pneumonia, 173 died, according to ministry data.
Last year, AstraZeneca K.K., the Osaka-based Iressa importer, printed a patient form that listed difficulty in breathing and other conditions that may develop as side effects, but it failed to spell out more life-threatening ones, including interstitial pneumonia.
A patient form is a document voluntarily made by a drugmaker to help doctors give explanations to patients about the drugs. The makers are not legally obliged to create such documents.
The Health, Labor and Welfare Ministry ordered the firm to revise the form in January, which then read that Iressa users “may result in a fatal process from interstitial pneumonia.”
Members of the ministry’s drug safety team then pointed out that the form was difficult to understand, prompting the ministry to order the importer to elaborate on the drug’s risks, the sources said.
It has told the firm to mention specific data, including the number of people who died from the drug’s side effects and the fact that one in three patients who developed interstitial pneumonia after taking the drug has died.
The ministry approved the use of Iressa after an unusually short screening period of five months.
But on Oct. 15, it ordered the firm to issue emergency safety notices on the drug’s side effects to medical institutions due to the reports of deaths.
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