Iressa FDA Alerts
The FDA Alert(s) below may be specifically about Iressa or relate to a group or class of drugs which include Iressa (gefitinib).
MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings. For the latest FDA MedWatch alerts, go here.
Recent FDA Alert(s) for gefitinib
Jun 17, 2005
Audience: Oncology healthcare professionalsAstraZeneca and FDA notified healthcare professionals of new approved labeling for Iressa that states the medicine should be used only in cancer patients who have already taken the medicine and whose doctor believes it is helping them. New patients should not be given Iressa because in a large study Iressa did not make people live longer. There are other medicines for non-small cell lung cancer (NSCLC) that have shown an ability to make people live longer.
[June 17, 2005 - Public Health Advisory - FDA]
[June 17, 2005 - Drug Information Page - FDA]