JAPAN’S Ministry of Health and Welfare is considering banning Iressa, AstraZeneca’s controversial lung cancer drug, after accepting a report that linked the medicine to 588 deaths in the country — more than four times the number previously thought.

An official spokesman for the ministry told The Times last night that the findings would raise the “possibility” that Iressa would be now be withdrawn. The report, compiled by a panel of scientists, concludes that 1,473 patients suffered side effects after taking Iressa and that the drug was linked to 588 deaths.

An earlier investigation had put the number of deaths linked to the medicine at 124.

The findings form part of an emergency investigation into the safety and efficacy of Iressa ordered in late December after AstraZeneca said the drug had proved no more effective than a dummy pill in prolonging the life of lung cancer sufferers.

Official confirmation that the drug’s regulatory status is under review goes further than an earlier statement, published yesterday morning, in which the ministry said only that it would be “premature” to restrict the use of Iressa.

A spokesman for the company said last night that it had been encouraged by the ministry’s response to the report: “We view the discussions with the Ministry of Health as being constructive and the outlook for Iressa as being very positive. The regulatory status of Iressa in Japan is unchanged.”

Any decision to ban Iressa in Japan would be another setback for AstraZeneca, which faces question marks over the safety of Crestor, a key drug in its portfolio, and difficulties in bringing a further potential blockbuster, Exanta, to the market. While a recent trial of Iressa had proved disappointing, scientists had drawn some hope from data that appeared to show that oriental patients responded better than others to the treatment.

Japan makes up more than 40 per cent of the total sales of Iressa, which in the first nine months of the financial year were worth $305 million (£163 million).

The full version of the Japanese report, due in March, is expected to play a key role in legal cases being brought against AstraZeneca’s Osaka-based subsidiary and the Health Ministry itself for allowing the drug to be approved.

Two families of victims killed by side-effects of Iressa are suing for about 30 million yen (£150,000). A lobby group has been set up to help living victims and the bereaved to fight further cases, which lawyers think are likely to snowball into billions of yen.

Doctors who supplied information to the new report said that Iressa, known locally as Gefitinib, reportedly caused side effects including interstitial pneumonitis, a form of pneumonia.

AstraZeneca said that the disease is associated with most therapies for lung cancer as well as the cancer itself. A company spokesman added that the lawsuits had no merit and that the company would vigorously defend them.

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