Riyadh, March 7, 2008 – The Canadian counterpart to the Saudi Food and Drug Authority (SFDA), Health Canada, announced new warnings in the prescribing information for the iron reducing drug deferasirox (Exjade) about the possibility of liver toxicity including liver failure.

Deferasirox (Exjade) is marketed in Saudi Arabia for the treatment of iron overload (excess iron) known as hemosiderosis in patients who require frequent blood transfusions. When blood cells breakdown iron is released that can accumulate in tissues causing painful joints, pancreatic, heart and liver damage. Hemosiderosis is also seen in patients with thalassemia.

The Canadian authorities report that there have been 24 international cases of liver failure. Of these 24 cases, 21 were postmarketing reports and three were from clinical trials. Canada accounted for two of the 24 cases. The majority of the reports of liver failure involved patients with significant comorbidities, including liver cirrhosis and multi-organ failure. According to Health Canada no patient with normal baseline liver function or without additional serious complications of their underlying disease has developed hepatic failure.

The Internet link for the new Canadian safety information concerning Deferasirox is .

The U.S. Food and Drug Administration (FDA) reviewed deferasirox’s safety in the Fall 2007 issue of the agency’s FDA Drug Safety Newsletter. Between November 2, 2005, and June 20, 2006, the U.S. FDA received 108 unduplicated reports of serious suspected adverse drug reactions associated with the use of deferasirox.

Of these 108 reports, there were 17 unduplicated cases of death; hospitalization was reported for 74 patients; the adverse reaction was life threatening in six cases; disability was the result in four instances; and an additional medical intervention was needed in one case. For the cases in which death was reported as the outcome, the cause reported in many cases was the result or progression of the patient’s underlying disease.

The commonly reported adverse events involved the gastrointestinal (GI) system, including the liver, kidneys, and blood. The table below list the type and number of adverse reactions reported to the U.S. authorities.

ACTIONS THAT PATIENTS AND HEALTHCARE PROFESSIONALS SHOULD FOLLOW:

• A number of laboratory tests may be required to use deferasirox safely and effectively. Patients should keep all appointments for laboratory tests ordered by their physicians.
• Healthcare professionals should monitor patients prescribed deferasirox for the possibility of kidney and liver toxicity and blood dyscrasias.

REPORT ADVERSE DRUG REACTIONS TO THE SFDA:
The public and health professionals are encouraged to report adverse drug reactions the National Pharmacovigilance Center on the Internet at
.