(JP)124 deaths tied to cancer drug

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http://www.japantimes.co.jp/cgi-bin/getarticle.pl5?nn20021226a3.htm

 

124 deaths tied to cancer drug

Nearly 500 hit by side effects of lung treatment

Iressa

 

Nearly 500 people have experienced debilitating side

effects from the British-made lung cancer drug Iressa,

and more than 120 of the patients have died, the

Ministry of Health, Labor and Welfare said Wednesday.

 

As of Dec. 13, 124 people had died from taking the

drug, the ministry said.

 

Of these, 114 were among 358 people who experienced

severe lung damage, including interstitial pneumonia.

Ten other victims were among 136 patients who reported

other kinds of side effects, including liver

dysfunction.

 

The drug, manufactured by AstraZeneca Group PLC of

Britain, is sold under the Iressa brand. It was

approved in July by the ministry after five months of

screening -- an unusually short period.

 

The figures were disclosed by an expert panel set up

by the ministry to investigate the problems after it

was revealed that 81 patients had died from side

effects related to the drug as of November. At that

time, 18,000 cancer patients were being treated with

it.

 

The ministry plans to only allow doctors who

specialize in cancer drugs to use Iressa, the

officials said, adding it is very abnormal for such a

large number of people to die from side effects in

such a short period of time.

 

The ministry decided to set up the panel because,

despite the problems, the drug has also received some

positive evaluations, including that it has potent

cancer-fighting effects.

 

The panel examined the safety of the drug on the basis

of reports submitted by the manufacturer covering the

symptoms of those patients who suffered side effects.

 

The panel decided to advise doctors to take special

measures, including admitting patients into hospitals

right after they are administered the drug, the

officials said.

 

Side effects very often take place within two weeks

after the drug is taken, they added.

 

The drug, which prevents the functions of receptors

linked with cancer-cell multiplication by targeting

molecules, has been considered highly potent in

combating advanced lung cancer.

 

But such a powerful drug has never been used by such a

large number of people, they added.

 

The drug had been widely touted as a miracle drug in

Japan. But clinical tests in Europe and North America

have found the rate of effectiveness of Iressa is as

low as 10 percent, and no country other than Japan has

approved the drug.

 

AstraZeneca has reportedly applied to sell the drug in

the United States and Switzerland. The U.S. government

was expected to approve it in November but has been

delaying action due to the reported deaths in Japan.

 

The Japan Times: Dec. 26, 2002

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