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Drug Notebook

FDA Alerts

Special Alerts:

[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 imatinib (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. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2006/safety06.htm#Gleevec, http://www.fda.gov/medwatch/safety/2006/Gleevec_101906_HCPletter.pdf and http://www.fda.gov/medwatch/safety/2006/Gleevec_PI_Sep2006.pdf.

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imatinib
(i MAT in ib)
NVR / SL | 400 mgNVR / SL   400 mg
bottle, 30 each Imatinib Mesylate 400mg, Oral tablet, yellow-orange, oblong-shaped, side 1:NVR, side 2:SL
SL SL / SL | 400 mgSL SL / SL   400 mg
bottle, 30 each Imatinib Mesylate 400mg, Oral tablet, orange-brown, biconvex, oval-shaped, scored, side 1:SL SL, side 2:400
S A / NVR | 100 mgS A / NVR   100 mg
bottle, 100 each Imatinib Mesylate 100mg, Oral tablet, yellow-orange, biconvex, round-shaped, scored, side 1:S A, side 2:NVR
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