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Gleevec FDA Alerts

The FDA Alert(s) below may be specifically about Gleevec or relate to a group or class of drugs which include Gleevec (imatinib).

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 imatinib

Gleevec (imatinib mesylate)

Oct 19, 2006

Audience: Oncology and cardiology healthcare professionals

[Posted 10/19/2006] Novartis and FDA notified healthcare professionals about revisions to the PRECAUTIONS section of the prescribing information, describing the occasional occurrence of severe congestive heart failure and left ventricular dysfunction in patients taking Gleevec. Most of the patients with reported cardiac events had other co-morbidities and risk factors, including advanced age and previous medical history of cardiac disease. Patients with cardiac disease or risk factors for cardiac failure should be monitored carefully and any patients with signs or symptoms consistent with cardiac failure should be evaluated and treated.

[October 19, 2006 - Letter - Norvartis]

More Gleevec Resources