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Iressa causes death in patients
Excerpted from story by
By Yuka Obayashi (Reuters Health, 2/03)
By January 31, the number of deaths had risen to 173 people. A current total of 473 have developed disorders of the lung that can be linked to Iressa. This includes interstitial pneumonia.
"The fatality figure did not include patients who died from side-effects other than lung disorders. A previous report in December linked 10 out of 124 deaths at that time to those other side-effects. No updated total of deaths was available."
As of January, an estimated 23,500 patients were being treated with Iressa, which is used to treat non-small-cell lung cancer.
Iressa is the first in a new class of epidermal growth factor receptor inhibitors that target proteins produced only by cancer cells, and do not cause the nausea and hair-loss associated with chemotherapy.
This drug became available in Japan but is now being examined more closely with new rules being proposed for treating lung cancer patients. Now patients must stay in the hospital for at least 4 weeks after taking the drug.
"The ministry is also restricting the use of Iressa to medical institutions capable of treating patients with sudden side effects, meaning only large hospitals are able to use it."
AstraZeneca, manufacturer of the drugs has asked Japanese doctors to keep track of these cases and not to prescribe the drug, or use 'extreme' caution, in patients with weakened lung function or prior history of interstitial pneumonia.
"The recommendation also includes stopping the prescription as soon as any signs of lung disorders are found.
Martin Wright, president of AstraZeneca's Japanese subsidiary, said the rate of lung disorder side effects had declined in the past three weeks, apparently due in part to the government's restrictions."
"The same trend is seen in early February, but it's too early to come to a conclusion," he said.
The specialist group will continue its study of past side-effect cases while AstraZeneca plans to conduct another detailed study on 5,000 patients, the company said.
FDA's reporting deadline had now been pushed back to May 5, as AstraZeneca awaits further review.
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