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8/10/1998

Modifications in Rezulin Prescribing Requirements

Cheryl A. Thompson

New product labeling for Rezulin recommends practitioners measure alanine aminotransferase (ALT) levels at the start of therapy and monthly for eight months, then every two months for the remainder of the first year and periodically thereafter. 

Patients with ALT levels greater than 1.5 times the upper limit of normal at the start of therapy should not receive Rezulin. Patients with ALT levels greater than 1.5 to 2 times the upper limit of normal during therapy should have ALT levels rechecked within a week and then weekly until normal levels return. If ALT levels rise to about 3 times the upper limit of normal, Rezulin should be discontinued. 

Additional recommendations include increasing the daily dose to 600 mg if patients do not respond to 400 mg after one month of therapy. If patients do not respond to 600 mg after one month of therapy, Rezulin should be discontinued. 

More information is available on the FDA's Web site. 

Previous FDA Statements 

Posted 8/10/98 — Source FDA.