Thursday, May 17, 2012

A new alert of prescription oral medication Deferasirox, impairment or failure of renal, hepatic, and gastrointestinal hemorrhage

Friday, February 19, 2010 14:03

exjade deferasirox tabletsPatients with chronic anemia and ?-thalassemia usually have a treatment with blood transfusion for certain time and the body possible to receive the iron from any causes.

Overload iron in the body as an accumulation during long period of blood transfusion may lead to iron overload disorder. Therefore from overload iron in the body leads to hereditary disease that can impact to other organs such as adrenal glands, liver, pancreas, and heart function.

As the results from overload iron in the body, patient will have significant risk to adrenal insufficiency, loss of liver function (cirrhosis), heart failure, and diabetes.

To reduce the overload iron, the doctor may use an oral iron chelator. One of them is Deferasirox which marketed as Exjade from Novartis company.

However, from recent alert by FDA, this drug also could leads to the risk of impairment or even failure of renal, hepatic, gastrointestinal hemorrhage.

Therefore FDA and drug company updated the Prescribing Information (PI) including new boxed warning states due to this adverse effects.

The PI states;
“Reaction were more frequently observed in patients with advanced age, high-risk myelodysplastic syndromes, underlying renal or hepatic impairment or low platelet counts (<50 x 109/L).”

The clinicians who treat their patients with this medication should monitor serum creatinine and/or creatinine clearance, serum transaminases, and bilirubin level, as specified in the PI.

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