Japan - The Pharmaceutical Affairs Bureau has announced safety measures to be taken for use of gefitinib (Iressa®) following the announcement of deaths associated with use (1).

Gefitinib is the first in a new class of epidermal growth factor receptor inhibitors targeting proteins produced only by cancer cells. It is seen as a promising new treatment for terminally ill lung cancer patients.

The new safety measures require that:

• Only experienced physicians should prescribe the drug and it should only be used in facilities able to respond to serious side effects.

• The patient should be kept under hospital surveillance for the first four weeks of therapy in the event that adverse drug reactions such as interstitial pneumonia occur.

To date, gefitinib has ben administered to more than 42 000 people worldwide. Interstitial lung disease and interstitial pneumonia are known complications of many lung diseases, including advanced lung cancer. Patients and physicians should be informed of the potential risk and watch for any signs and symptoms (2).

References

1. Pharma Japan, Numbers 1826, 30 December 2002 & 1837, 24 march 2003.

2. AstraZeneca update regarding Iressa (ZD1839). http://www.astrazeneca-us.com