© 2001-2003 PFPC

UPDATE:  Feb.7, 2003: Death Toll Climbs to 167

Oct. 28, 2002

   On the weekend, the government in Japan announced that the fluorophenyl-containing anticancer drug "Iressa" had caused 39 deaths, out of 125 "side-effects" reported - as of Saturday, Oct. 26.

   It has also been linked to 86 cases of serious lung disease including interstitial pneumonia. Liver inflammation was commonly seen.

   Iressa has been taken by approximately 10,000 people in Japan since it was approved a few months ago for the treatment of lung cancer. The drug has been on the market only since July 2002.

   Although not yet approved in the US, over 11,000 patients in the US have received the drug, according to AstraZeneca documents.

   Iressa (aka Gefitinib or Z-1839) is the first of a new class of drugs designed to inhibit the epidermal growth factor (EGF) which is over-expressed in numerous cancers.

   Iressa had been "fast-tracked" for approval in Japan where it became the second fastest drug approval ever. The drug is made by Europe's second-biggest drugmaker, AstraZeneca , who had anticipated worldwide sales of $1 billion a year for the drug.

   The drug was to be a major player in the world wide market for lung-cancer treatment which is set to skyrocket from its present $1.6 billion to $ 8 billion in 2011.

   On Oct. 15, AstraZeneca was instructed by Japan's Health, Labor and Welfare ministry to inform medical institutions of the new knowledge on the safety of the drug.

   The company then claimed only 11 deaths out of 22 total severe side effects, although the drug's importer knew that at least 27 people had died and 69 had suffered side-effects.

   At a press-conference later that day, AstraZeneca raised its figures to 26 affected patients, including 13 deaths.

   The ministry conducted its own review and found more deaths which had not been reported.

   When challenged on its false figures, AstraZeneca pointed out that Japan's Pharmaceutical Affairs Law requires pharmaceutical companies to report any significant side effects of its drugs to the ministry within 30 days of the company being informed of such cases, admitting that it had only reported cases "close to the due date".

   "It was an inappropriate decision,"  AstraZeneca spokeswoman Fumiko Muramoto said.

   Earlier, on August 19th, 2002 the financial magazine Forbes reported that AstraZeneca shares went down 16% after the company was forced to announce that the drug had NOT helped lung-cancer patients when combined with chemotherapy.

See PFPC: Fluoride in Drugs


"AstraZeneca backs Iressa after more deaths"
Forbes/Reuters, Oct.27, 2002

"AstraZeneca files Iressa for FDA approval for cancer therapy" Reuters News, Aug.7 (2002)

"AstraZeneca Drug Trial Fails, Shares Down"
Reuter's Business Report, Aug. 19 (2002)

"Side effects of AstraZeneca anticancer drug kills 39 in Japan" Associated Press -  Oct. 27, 2002

"26 more anticancer drug deaths reported"
The Daily Yomiuri (Japan) - Oct. 28, 2002