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Exjade (deferasirox) tablets for oral suspension.


WARNINGS: Hepatic Dysfunction and Failure

In Study 1, 4 patients discontinued Exjade because of hepatic abnormalities (drug-induced hepatitis Hepatitis, Drug-Induced Definition

Inflammation of the liver due to an adverse reaction with a drug.
Description

The liver is a very important organ to the body.
 in 2 patients and increased serum transaminases in 2 additional patients). There have been postmarketing reports of hepatic failure, some with a fatal outcome fatal outcome,
n a consequence that results in death. The course of a disease that results in the death of the patient.
, in patients treated with Exjade. Most of these events occurred in patients greater than 55 years of age. Most reports of hepatic failure involved patients with significant comorbidities, including liver cirrhosis liver cirrhosis
(sirō´sis),
n a degenerative disease of the liver in which hepatic tissue is replaced with connective tissue, commonly a result of chronic alcoholism. See jaundice.
 and multi-organ failure. Liver function tests Liver Function Tests Definition

Liver function tests, or LFTs, include tests for bilirubin, a breakdown product of hemoglobin, and ammonia, a protein byproduct that is normally converted into urea by the liver before being excreted by the kidneys.
 should be monitored monthly during Exjade treatment and dose modifications or interruption considered for severe or persistent elevations.

ADVERSE REACTIONS

Postmarketing Experience

Hepatic Failure
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Title Annotation:Contraindications and warnings
Publication:Adverse Event Reporting News
Article Type:Brief article
Geographic Code:1USA
Date:May 6, 2008
Words:103
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