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EDITIONS
 Wednesday, 25 December, 2002, 07:47 GMT
Japan restricts 'lethal' cancer drug
Pharmaceutical laboratory
AstraZeneca chose not to halt sales of the drug
The Japanese Health Ministry has said it would impose stricter rules on the use of a lung cancer drug, which it said had been linked to the deaths of 124 patients.

The ministry said the dead were among 494 patients who have developed severe side-effects after using the drug, Iressa, which went on sale in Japan in July.

The ministry said only lung cancer specialists would now be able to prescribe the drug, and patients receiving it would have to stay in hospital.

Iressa is intended to treat inoperable or recurring cases of lung cancer that are at an advanced stage.

The drug is manufactured by the Japanese unit of the British pharmaceutical giant, AstraZeneca, and is only available in Japan.

Close monitoring

The ministry said the move was recommended by a panel of 12 drug experts after they studied side-effects of Iressa.

Doctors would now be required to thoroughly explain the risks of taking the red tablets to patients and their families.

Patients will also have to remain in hospital for at least four weeks after beginning to take the drug so they can be closely monitored.

AstraZeneca KK - the company's Japanese unit - upgraded its prescription warning to doctors in October, but decided against halting sales of the drug.

Iressa went on sale in Japan after early studies showed that lung cancer patients had recovered impressively by taking the drug.

See also:

19 Aug 02 | Business
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12 Aug 02 | England
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24 Jul 02 | Business
15 Jul 02 | Business
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