Families of patients who died after experiencing side effects from the lung cancer drug Iressa urged the government Friday to order British pharmaceutical maker AstraZeneca PLC to stop selling it because tests have shown it ineffective at prolonging life.
A group of families and lawyers said it has filed the request with the Health, Labor and Welfare Ministry, and mailed it to AstraZeneca K.K., the British firms’s Japanese subsidiary in Osaka.
The clinical trial, conducted by AstraZeneca on more than 1,600 people in 28 countries excluding Japan, showed that lung cancer patients who took Iressa did not live any longer than those who did not.
“The trial clarified that the drug does not provide any benefits for lung cancer patients,” the group of patients’ families said.
AstraZeneca was reportedly first launched in Japan, where it was linked to cases of pneumonia.
An official at the health ministry division in charge of ensuring medicine safety said it would look into the matter by asking the firm’s Osaka subsidiary to submit detailed reports on the controversial drug.
After the test results were released earlier this month, the U.S. Food and Drug Administration, which approved Iressa in May 2003, issued a statement saying it would consider measures to restrict use of the drug, including taking it off the market.
In Japan, the bereaved family of Mitsuko Chikazawa, which is leading the group of cancer victims’ families, has filed a damages suit for 38.5 million yen against the state and the distributor of the lung cancer drug, claiming they failed to inform doctors of the risk of serious side effects.
Chikazawa, a Saitama Prefecture woman who was found to have lung cancer in October 2001, died of pneumonia that developed as a result of taking Iressa.